[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ewing-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ewing-sarcoma":682},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,49,75,99,125,160,188,209,238,266,287,310,330,360,393,419,444,473,498,525,547,559,579,608,639],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054031",false,"NCT06796543","Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma","TARGET-RT","Stratum A Inclusion Criteria:\n\n* Patients must be aged \\\u003C 39 years at time of enrollment.\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site.\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan within 3 weeks from treatment start.\n\nStratum B Inclusion Criteria:\n\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1.\n* Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age \\\u003C 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent).\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan\n* Radiation to at least one site is being recommended as part of second line therapy.\n\nStratum A Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present.\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy\n\nStratum B Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy","ALL","39 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.",[26,27,28,29],"Metastatic Sarcoma","Radiation Therapy Patient","Ewing Sarcoma","Rhabdomyosarcoma",[31,26,32,29,33,34,35],"Pediatric","Ewing sarcoma","Brain tumor","Longitudinal","Radiation Therapy","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2025-03-25",{"date":44,"type":20},"2030-03",{"name":46,"class":47},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",3,{"id":50,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100632525","NCT07514819","Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.\n* Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.\n* Research participant or legal guardian\u002Frepresentative gives written informed consent.\n\nExclusion Criteria:\n\n* Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.\n* Participants who are diagnosed with Wilm's tumor or neuroblastoma\n* Participants who do not undergo proton therapy.\n* Participants who are prescribed equal or less than 5 fractions of proton therapy.\n* Participants with severe comorbid conditions that may impact imaging feasibility.\n* Inability to obtain written consent from research participant or legal guardian\u002Frepresentative.\n* Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \\>10 years of age or post-menarchal must have a negative serum or urine pregnancy test\n\nAll participants receiving proton therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria and the Exclusion Criteria. Qualified candidates will be selected during the consultation.",{"count":55,"type":20},100,[23],"Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.\n\nPrimary Objective:\n\n* Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.\n* Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.\n\nSecondary Objectives\n\n* Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.\n* Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.",[59,29,28,60,61,62,63],"Pediatric Solid Tumors","Osteosarcoma","Hodgkin Lymphoma","Bone Tumor","Soft Tissue Sarcoma","NOT_YET_RECRUITING","2026-06-30",{"date":67,"type":40},"2026-07-02",{"date":69,"type":20},"2026-08",{"date":71,"type":20},"2031-08",{"name":73,"class":47},"St. Jude Children's Research Hospital",1,{"id":76,"slug":4,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100557680","NCT06541262","Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors","Phase I\u002FII Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors","Inclusion Criteria:\n\n1. Age: Less than 30 years old at initial diagnosis\n2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed\u002Frefractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma\n\n   Phase II:\n   * Relapsed\u002Frefractory Neuroblastoma\n   * Relapsed\u002Frefractory Ewing sarcoma\n3. Tumor assessment:\n\n   Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed\u002FRefractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol) and has now relapsed and is in any number of relapses.\n\n   Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy.\n\n   International Neuroblastoma Risk Group Staging System (INRG) High Risk NB defined as one of the following:\n   1. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification\n   2. Age ≥ 547 days and INRG Stage M regardless of biologic features\n   3. Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy\n   4. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy\n\n   Relapsed\u002Frefractory Sarcoma Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n5. Measurable or evaluable disease, including at least one of the following:\n\n   * Measurable tumor by CT or MRI\n   * MIBG or PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n6. Timing from prior therapy:\n\n   Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer therapy and be within the following timelines:\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study.\n   2. Small Molecule Inhibitors (anti-neoplastic agent): At least 2 weeks from the completion of therapy with a small molecule inhibitor.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells, anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.).\n   4. Radiotherapy: At least 30 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n   5. Stem Cell Transplant:\n\n      * Allogeneic: No evidence of active graft vs. host disease\n      * Allogeneic\u002FAutologous: ≥ 2 months must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n7. Subjects must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 50.\n8. Subjects must have adequate organ function at the time of enrollment:\n\n   * Cardiac: Subjects must have a QTcF ≤ 480 msc.\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C5x upper limit of normal\n   * Renal: Subjects must have adequate renal function defined as:\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects \\\u003C 17 years old) (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n9. Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy.\n10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).\n\nExclusion Criteria:\n\n1. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.\n2. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.\n3. Subjects who are currently receiving Vitamin K antagonists (warfarin).\n4. Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).\n5. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n7. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n8. Subjects with any of the following gastrointestinal disorders:\n\n   1. Active malabsorption (e.g. short gut) syndrome.\n   2. Uncontrolled diarrhea (excess of 4 stools\u002Fday)\n   3. Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis\n   4. History of gastric or small bowel surgery involving any extent of gastric or small bowel resection\n9. Lactating subjects are not eligible unless they have agreed to not breastfeed their infants. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing subject with silmitasertib. (NOTE: breast milk cannot be stored for future use while the nursing subject is being treated on study.)\n10. Subjects with a history of any other malignancy.","30 Years",{"count":83,"type":20},104,[85,86],"PHASE1","PHASE2","The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of silmitasertib in combination with chemotherapy\n* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[89,28,60,29,90],"Neuroblastoma","Liposarcoma",{"date":67,"type":40},{"date":93,"type":40},"2024-10-30",{"date":95,"type":20},"2035-11-01",{"name":97,"class":47},"Milton S. Hershey Medical Center",22,{"id":100,"slug":4,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100551831","NCT06465199","Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas","A Phase I\u002FII Study Using Eflornithine (DFMO) and AMXT 1501 for Relapsed and Refractory Neuroblastoma, CNS Tumors, and Sarcomas","Inclusion Criteria:\n\n1. Age:\n\n   All participants : Must be a maximum of 26 years of age at diagnosis\n\n   Age at enrollment by Phase:\n   1. Safety Run-in (Dose level 1)-The first three (3) participants enrolled will be ≥ 12 years of age at enrollment. Once evaluated for safety by DSMB, we will move on to the next three (3) participants enrolled who will be ≥6 years of age at enrollment. Once evaluated for safety by DSMB, we will move on to the Phase I.\n   2. Phase I and II: ≤ 26 years of age at diagnosis.\n2. Pathology\n\n   All participants must have a confirmed pathologic diagnosis of tumor type (except for DIPG):\n   * Relapsed\u002Frefractory Neuroblastoma (NB)\n   * Relapsed\u002Frefractory Embryonal tumor with multilayer rosettes (ETMR)\n   * Relapsed\u002Frefractory Atypical teratoid rhabdoid tumor (ATRT)\n   * Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)- radiologic diagnosis acceptable\n   * Relapsed\u002Frefractory Ewing Sarcoma (EWS)\n   * Relapsed\u002Frefractory Osteosarcoma (OST)\n3. Tumor assessment:\n\n   Disease staging must be performed at baseline during the 28 day screening period prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed or Refractory Neuroblastoma Relapsed disease defined as: High-risk neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation, surgery, and immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol).\n\n   Refractory disease defined as: High-risk neuroblastoma that 1) failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol, or 2) progression during upfront therapy or 3) with disease remaining after standard immunotherapy.\n\n   Eligible NB participants may have active disease or no active disease.\n\n   NB participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   NB participants with active disease need to meet the following criteria:\n   * Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n   * Participants must not have disease in any organs (including lungs, liver, or brain).\n\n   Relapsed or refractory ETMR\u002FATRT Participants that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive\u002Fprogressive to accepted curative therapy, including up-front chemotherapy and radiation and\u002For high-dose chemotherapy with stem cell rescue.\n\n   ETMR\u002FATRT participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   ETMR\u002FATRT participants with active disease need to meet the following criteria:\n\n   • Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n\n   Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) Participants with DIPG to start greater than 30 days, and no longer than 60 days, after standard of care radiation therapy.\n\n   Participants with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of the pons on at least 1 axial T2-weighted image, are eligible. No histologic confirmation is required. Participants with metastatic disease are not eligible. Participants with a biopsy and no evidence of H3K27m mutations are eligible as long as they meet radiographic criteria. Participants with H3K27m altered DMG outside of the brainstem are not eligible. Participants with progression or recurrence after initial standard of care radiation are ineligible.\n\n   Relapsed or refractory Ewing sarcoma and osteosarcoma Participants that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for Ewing sarcoma and osteosarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n\n   EWS\u002FOST Participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   EWS\u002FOST Participants with active disease need to meet the following criteria:\n\n   • Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n5. Participants must be able to swallow capsules.\n6. Participants with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week and must not have progressive hydrocephalus at enrollment.\n7. Participants must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:\n\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).\n   2. Small Molecule Inhibitor (anti-neoplastic agent): At least 7 days since the completion of therapy with a small molecule inhibitor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells except for anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.) which should be at least 2 weeks since prior treatment with a monoclonal antibody.\n   4. XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n\n      Note: Participants with DIPG will be required to have had up front standard of care radiation. As above, participants with DIPG must be between 30-60 days post initial up- front radiation therapy.\n   5. Stem Cell Transplant:\n\n      1. Allogeneic: No evidence of active graft vs. host disease\n      2. Allo\u002FAuto: ≥ 45 days must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n8. Participants must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 60\n9. Participants must have adequate organ function at the time of enrollment:\n\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL (unsupported- \\>24 hrs off G-CSF and 7 days off neulasta)\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C10x upper limit of normal\n   * Cardiac: all participants must have:\n\n     1. Normal serum Cardiac Troponin Concentration\n     2. Normal BNP (B-type natriuretic peptide) Level\n     3. A QTcF ≤ 470 msec (or EKG with no significant findings)\n     4. Normal ECHO defined as:\n\n     i. Shortening fraction of ≥ 27% by echocardiogram, or ii. Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n   * Renal: Participants must have adequate renal function defined as:\n\n     1. For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     2. For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n10. Participants of childbearing potential must have a negative pregnancy test. Participants of childbearing potential must agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n11. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n4. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n5. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.","26 Years",{"count":107,"type":20},289,[85,86],"The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of AMXT 1501 in combination with DFMO\n* Test the safety and tolerability of AMXT 1501 in combination with DFMO\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[111,112,28,113,60,89,114],"Atypical Teratoid\u002FRhabdoid Tumor","Embryonal Tumor With Multilayered Rosettes","Diffuse Intrinsic Pontine Glioma","DIPG Brain Tumor",[116],"DFMO",{"date":118,"type":40},"2026-07-01",{"date":120,"type":40},"2026-05-13",{"date":122,"type":20},"2035-05",{"name":97,"class":47},12,{"id":126,"slug":4,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":148,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":74},"100564132","NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months","25 Years",{"count":134,"type":20},27,[85,86],"Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[89,29,138,139,140,141,142,143,144,145,146,60,28,147],"Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Chordoma","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor","Wilms Tumor",[149,150,151],"pediatric solid tumors","stem cell transplantation","graft manipulation","2026-06-25",{"date":65,"type":40},{"date":155,"type":40},"2026-02-11",{"date":157,"type":20},"2030-02",{"name":159,"class":47},"University of Florida",{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":74},"100395755","NCT04433221","Combination Immunotherapy Targeting Sarcomas","Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas","Inclusion Criteria:\n\n1. Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;\n2. Age: ≥ 6 months and ≤80 years of age at the time of enrollment;\n3. At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment;\n4. Side effects of chemotherapy have been well managed;\n5. Confirmed malignant cell expression of CART target antigens by IHC or flow\n6. Karnofsky \u002Fjansky score of 50% or greater;\n7. Expected survival \\> 8 weeks;\n8. ANC≥ 1×10\\^6\u002FL，PLT ≥ 1×10\\^8\u002FL;\n9. Pulse oximetry of≥90% on room air；\n10. Adequate hepatic function, defined as aspartate aminotransferase(AST)\\\u003C 5 times upper limit of normal(ULN),serum bilirubin \\\u003C 3 times ULN;\n11. Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed;\n12. Patients must have sufficient autologous CART cells at does greater than 0.5x10\\^6 cells\u002Fkg body weight;\n13. Sign an informed consent and assent.\n\nExclusion Criteria:\n\n1. The disease is progressing rapidly;\n2. The patient is receiving therapy of other new drugs and under evaluation;\n3. Evidence of tumor potentially causing airway obstruction;\n4. Epilepsy history or other CNS diseases;\n5. Patients who need immunosuppressive drugs;\n6. History of long QT syndrome or severe heart diseases;\n7. Uncontrolled active infection;\n8. Active hepatitis B virus, hepatitis C virus or HIV infection;\n9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;\n10. Previous treatment with any gene therapy;\n11. Creatinine\\>2.5mg\u002Fdl or ALT\u002FAST\\>3 times normal or bilirubin\\>2.0 mg\u002Fdl;\n12. Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined;\n13. Pregnant or lactating women;\n14. Patients previously experienced toxicity from cyclophosphamide and doxorubicin;\n15. Patients who have CNS sarcoma;\n16. In condition that may bring risks to subjects or interference to clinical trials.","1 Year","75 Years",{"count":169,"type":20},20,[85,86],"The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.",[173,174,28],"Sarcoma","Osteoid Sarcoma",[173,176,177,178,179],"Chemotherapy","Doxorubicin","CART","Vaccine","2026-06-18",{"date":182,"type":40},"2026-06-23",{"date":118,"type":20},{"date":185,"type":20},"2029-12-31",{"name":187,"class":47},"Shenzhen Geno-Immune Medical Institute",{"id":189,"slug":4,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":167,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":74},"100313156","NCT03356782","Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas","Inclusion Criteria:\n\n1. Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;\n2. Age: ≥ 18 and ≤65 years of age at the time of enrollment;\n3. At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before enrollment;\n4. Side effects of chemotherapy have been well managed;\n5. Malignant cells are target antigen positive(higher than ++) confirmed by IHC, quantitative PCR or sequencing;\n6. Karnofsky \u002Fjansky score of 50% or greater;\n7. Expected survival \\> 6 weeks;\n8. ANC≥ 1×10\\^6\u002FL，PLT ≥ 1×10\\^8\u002FL;\n9. Pulse oximetry of≥90% on room air；\n10. Adequate hepatic function,defined as aspartate aminotransferase(AST)\\\u003C 5 times upper limit of normal(ULN),serum bilirubin \\\u003C 3 times ULN;\n11. Adequate renal function,defined as serum creatinine less than 2 times ULN,if serum creatinine more than 1.5 times ULN,creatinine clearance rate test is needed;\n12. Patients must have autologous transduced T cells at levels greater than 15%;\n13. Sign an informed consent and assent.\n\nExclusion Criteria:\n\n1. The disease is progresseing rapidly;\n2. The patient is receiving therapy of other new drugs;\n3. Evidence of tumor potentially causing airway obstruction;\n4. Epilepsy history or other CNS diseases;\n5. Patients who need immunosuppressive drugs because of GVAD;\n6. History of long QT syndrome or severe heart diseases;\n7. Uncontrolled active infection;\n8. Active hepatitis B virus,hepatitis C virus and HIV infection;\n9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;\n10. Previous treatment with any gene therapy;\n11. Creatinine\\>2.5mg\u002Fdl or ALT\u002FAST\\>3 times normal or bilirubin\\>2.0 mg\u002Fdl;\n12. Patients who have other uncontrolled diseases would preclude participation as outlined;\n13. Pregnant or lactating women;\n14. Patients previously experienced toxicity from cyclophosphamide;\n15. Patients who have CNS sarcoma;\n16. In condition that may bring risks to subjects or interference to clinical trials.",{"count":169,"type":20},[85,86],"The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines CAR T cells and IgT cells to treat sarcoma.",[173,174,28],[178,198,199,200,201,202],"PD-1","PDL-1","CTLA-4","sarcoma","solid tumor",{"date":182,"type":40},{"date":205,"type":40},"2026-06-01",{"date":207,"type":20},"2030-12-31",{"name":187,"class":47},{"id":210,"slug":4,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":74},"100560022","NCT06571734","XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma","A Non-Randomized, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma","Inclusion Criteria For Cohort 1 - Leiomyosarcoma:\n\n* Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria For Cohort 2 - Bone Sarcoma:\n\n* Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria For Cohort 3 - Translocation-associated Soft Tissue Sarcoma:\n\n* Patients must have histologically confirmed diagnosis of metastatic or unresectable translocation-associated soft tissue sarcoma (TAS). Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.\n* Patients must have undergone greater than 2 lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).\n\nInclusion Criteria for All Cohorts\u002FSarcoma Types\n\n* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.\n* Patients must be aged ≥ 18 years on day of signing any informed consent documents.\n* Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or \\> 70% on the Karnofsky Scale.\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (without granulocyte colony-stimulating factor support within 21 days of screening sample collection)\n* Hemoglobin (Hgb) ≥ 9 g\u002FdL without transfusion within 21 days of screening laboratory sample collection\n* Platelets (PLT) ≥ 100,000\u002Fmm\\^3 (\\> 100 GI\u002FL) without transfusion within 21 days of screening laboratory sample collection\n* International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal ULN; for patients with Gilbert's disease, total bilirubin ≤ 3 x ULN\n* Alanine aminotransferase (AST) ≤ 3 x institutional ULN\n* Aspartate aminotransferase (ALT) ≤ 3 x institutional ULN\n* Alkaline phosphatase (ALP) ≤ 3 x institutional ULN; for patients with documented bone metastasis, ALP ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 40 mL\u002Fmin ( ≥ 0.67 mL\u002Fsec) using the Cockcroft-Gault equation\n* Creatinine clearance ≥ 40mL\u002Fmin\n* Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg ( ≤ 113.12 mg\u002Fmmol)\n* Patient of child-bearing potential (POCBP) and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required\n* Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 96 days following completion of therapy\n* Patients must have ejection fraction \\> 50% by either MUGA scan or echocardiogram.\n* Patients must be capable of understanding and complying with the protocol requirements.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who have received previous treatment with XL092.\n* Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment.\n* Patients who have received \\> 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.\n* Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their prior therapy (toxicity and\u002For complications) such that they now meet all other eligibility criteria\n* Patients who have received radiation therapy for bone metastasis within 14 days prior to registration\n* Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment\n* Patients with clinically relevant complications from prior radiation therapy requiring ongoing therapy, per the opinion of the treating investigator enrolling the patient.\n* Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made:\n\n  * For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers, localized low-grade tumors deemed cured and not treated with systemic therapy, and incidentally diagnosed prostate cancer if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n  * For patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed. Note: Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n* Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin and factor Xa inhibitors) and platelet inhibitors (e.g., clopidogrel). Note: Allowed anticoagulants are low-dose aspirin for cardioprotection (per local applicable guidelines) and low molecular weight heparins (LMWH). Therapeutic doses of LMWH are not permitted in patients with brain metastases. Note: Patients must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first study treatment, whichever is longer.\n* Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks (14 days) prior to start of treatment. Note: taking complementary medications to treat symptoms of the cancer is allowed.\n* The patient has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes)\n    * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic of \\> 90 mm Hg diastolic despite optimal antihypertensive treatment\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant ischemic events within 12 months prior to first dose of study treatment. Note: Patients who did not require prior anticoagulant therapy may be eligible must be discussed and approved by the principal investigator (PI)\n    * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-cerebrovascular accident (CVA)\u002FTIA arterial thromboembolic events within 6 months before to first dose of study treatment.\n    * Prior history of myocarditis\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * Tumors invading the GI tract from external viscera\n    * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess must be confirmed prior to first dose of study treatment\n    * Known gastric or esophageal varices\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic\n* Patients with clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to registration.\n* Symptomatic cavitating pulmonary lesions or endobronchial disease (asymptomatic or radiated lesions allowed).\n* Lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta.\n\nNote: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena cava) may be eligible following PI approval\n\n* Patients who are capable of donating eggs for the purpose of reproduction must not do so throughout the course of the study and for 186 days after the last dose of treatment\n* Patients who are capable of donating sperm for the purpose of reproduction must not do so throughout the course of the study and for 96 days after the last dose of treatment\n* Other clinically significant disorders that would preclude safe study participation, including, but not limited to:\n\n  * Active infection requiring systemic treatment. Note: This criterion applies only at enrollment; if a patient develops an infection while on study treatment, they may continue to receive study treatment. Note: prophylactic antibiotic treatment is allowed\n  * Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness\n  * Known positive test for or suspected infection with SARS-CoV-2 within one month prior to enrollment. Note: Demonstration that the patient has fully recovered from the infection is required to be eligible for enrollment\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if they are due to tumor-associated skin lesions\n  * Malabsorption syndrome\n  * Pharmacologically uncompensated, symptomatic hypothyroidism\n  * Moderate to severe hepatic impairment (Child-Pugh B or C)\n  * Requirement for hemodialysis or peritoneal dialysis\n  * History of solid organ or allogenic stem cell transplant\n* Recent surgery within the following parameters:\n\n  * Major surgery (e.g., GI surgery or removal\u002Fbiopsy of brain metastasis) within 8 weeks prior to study treatment\n  * Minor surgery (e.g., simple excision, tooth extraction) within 5 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from said surgery must have occurred prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 5 days prior to registration. Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* Patients with any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) grade \\> 1 at baseline from a previous anticancer therapy, with the following exceptions:\n\n  * Alopecia, vitiligo, and the laboratory values\n  * Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with XL092 may be included only after consultation with the principal investigator\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to XL092\n* Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because XL092 is a next-generation tyrosine kinase inhibitor with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with XL092, breastfeeding should be discontinued if the nursing parent is treated with XL092. Note: If a urine pregnancy test is positive or cannot be confirmed negative, a serum pregnancy test will be required\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, per the opinion of the treating investigator\n* XL092 is administrated orally; patients who are unable to swallow, retain, and\u002For absorb pills are not eligible for this study\n* Patients who are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of treatment\n* Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study","18 Years",{"count":217,"type":20},73,[86],"This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma. The trial has now been expanded to treat additional sarcoma types that are sensitive to tyrosine kinase inhibitors (TKIs) such as translocation-associated soft tissue sarcoma (such as synovial sarcoma), and bone sarcoma (including osteosarcoma and Ewing sarcoma).",[221,222,223,224,225,226,28,227,228,229],"Metastatic Leiomyosarcoma","Unresectable Leiomyosarcoma","Bone Sarcoma","Translocation-associated Soft Tissue Sarcoma","Synovial Sarcomas","Osteosarcoma Metastatic","Ewing Sarcoma Metastatic","Sarcoma Metastatic","Sarcoma of Bone","2026-06-16",{"date":180,"type":40},{"date":233,"type":40},"2024-09-19",{"date":235,"type":20},"2033-07-01",{"name":237,"class":47},"Northwestern University",{"id":239,"slug":4,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":244,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":265},"100615851","NCT07297979","Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)","A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Xaluritamig in Adult, Adolescent and Pediatric Participants With Relapsed or Refractory Ewing Sarcoma","Inclusion Criteria:\n\n1. Part 1: evaluable disease as defined by RECIST v1.1, as determined by the site investigator.\n\n   Part 2: measurable disease as defined by RECIST v1.1, as determined by the site investigator.\n2. Histologically or cytologically confirmed EWS with molecular evidence of an EWSR1 translocation with an E26 transformation-specific (ETS) family gene, eg, FLI1, ETS-related gene \\[ERG\\]) via next generation sequencing (based on local testing).\n3. Relapsed or refractory EWS following at least 1 line of chemotherapy (including treatment with an anthracycline and at least 1 alkylating agent).\n4. Performance status:\n\n   1. Karnofsky ≥ 70% for participants ≥ 16 years of age.\n   2. Lansky ≥ 70% for participants \\\u003C 16 years of age.\n5. Adequate organ function, defined as follows:\n\n   a. Hematological function: i. Absolute neutrophil count ≥ 1.0 x 109\u002FL, provided that:\n   * the participant has not received short-acting growth factor support within 7 days before screening assessment, and\n   * the participant has not received long-acting growth factor support within 14 days before screening assessment.\n\n   ii. Platelet count ≥ 75 x 109\u002FL, provided that:\n   * the participant has not received a platelet transfusion within 7 days before screening assessment, and\n   * the participant has not received a platelet stimulating agent within 14 days before screening assessment.\n\n     b. Renal function: i. Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 for participants ≥ 18 years of age.\n\n   ii. estimated glomerular filtration rate based on Schwartz (2009) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 for participants \\\u003C 18 years of age.\n\n   c. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (or ≤ 5 x ULN for participants with liver metastases).\n\n   ii. Total bilirubin (TBL) ≤ 1.5 x ULN (unless related to Gilbert's or Meulengracht disease).\n\n   d. Pulmonary function: i. Baseline oxygen saturation \\> 92% in room air at rest and no oxygen supplementation.\n\n   e. Cardiac function: i. Left ventricular ejection fraction ≥ 50%. If left ventricular ejection fraction cannot be measured, then left ventricular fractional shortening ≥ 28%.\n6. Participants of childbearing potential must use protocol-specified contraception to prevent pregnancy during treatment and for an additional 6 months after the last dose of xaluritamig.\n\nExclusion Criteria:\n\n1. Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.\n2. History of other malignancy within the past 2 years, except for malignancy treated with curative intent with low risk for recurrence (approximately \\\u003C 10%) and with no known active disease present for \\>1 year before enrollment.\n3. Active autoimmune disease that has required systemic treatment (except physiologic adrenal hormone replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type 1 diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.\n4. Participants who received anti-cancer therapy administered within the following minimum washout periods prior to first dose of xaluritamig:\n\n   1. Cytotoxic chemotherapy: 21 days.\n   2. Small molecules including tyrosine kinase inhibitors: 7 days or 5 half-lives, whichever is shorter.\n   3. Monoclonal antibodies, immune checkpoint inhibitors, bispecific antibodies and other biologic agents: 28 days or 5 half-lives, whichever is shorter.\n   4. Cellular therapies including Chimeric Antigen Receptor T-cell therapy (CAR-T), adoptive T-cell therapy: 56 days.\n   5. Radiotherapy: 14 days for focal therapy, 28 days for large field therapy or involving \\> 30% of the bone marrow.\n   6. Stem cell transplant: 12 weeks for autologous, 6 months for allogeneic, with no active graft-versus-host disease.\n   7. Any other therapy or investigational agent: 28 days or 5 half-lives, whichever is longer.\n5. Requirement for chronic systemic corticosteroid therapy (prednisone dose \\> 10 mg\u002Fday \\[\\> 0.25 mg\u002Fkg\u002Fday if \\\u003C 40 kg\\] or equivalent) or any other immunosuppressive therapies (including anti-tumour necrosis factor α (TNFα) therapies) unless stopped (with adequate tapering) within 28 days before first dose of xaluritamig.\n6. Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of trial intervention.\n7. Unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of xaluritamig.","2 Years",{"count":246,"type":20},50,[85],"The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric participants with relapsed or refractory EWS.",[28],[251,252,253,254],"Relapsed or refractory Ewing sarcoma","EWS","Xaluritamig","AMG 509","2026-06-10",{"date":257,"type":40},"2026-06-11",{"date":259,"type":40},"2026-04-08",{"date":261,"type":20},"2030-05-26",{"name":263,"class":264},"Amgen","INDUSTRY",7,{"id":267,"slug":4,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":272,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100617691","NCT07321912","Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma","A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma","Cohort 1:\n\nInclusion Criteria:\n\n1. Participants must be ≤50 years of age at enrollment.\n2. Histologically confirmed Ewing sarcoma that is refractory or in first or subsequent relapse. Histological confirmation either at initial diagnosis or disease progression.\n\n   * Relapsed: Participants that have achieved CR at any point and then relapsed following\u002Fduring standard of care therapy.\n   * Refractory: Participants that failed to achieve CR after standard of care therapy or having progressed during standard of care therapy.\n   * Note: Standard of care therapy for Ewing sarcoma includes multi-agent chemotherapy with local control consisting of either surgery and\u002For radiation therapy.\n3. Extent of disease is judged by treating team to be amenable to the delivery of definitive local control (either definitive radiation, surgery, or a combination of these) at the time of study enrollment (to be completed after protocol defined Cycle 2).\n4. Participants may enroll anytime during Cycle 1 or 2, prior to local control, as long as they received the same treatment during Cycle 1 and 2 as prescribed in this protocol.\n5. Relapsed or refractory disease, including at least one of the following:\n\n   * Tumor by CT or MRI\n   * FDG-PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n\n   Organ Function Requirements:\n6. Participants must have adequate renal function as defined as:\n\n   * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n7. Adequate liver function defined as:\n\n   1. Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and\n   2. SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT \\\u003C 5 times ULN for age).\n8. Adequate cardiac function defined as:\n\n   1. Shortening fraction of ≥27% or\n   2. Ejection fraction of ≥50%\n9. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n10. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n11. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n12. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Participants with current CNS disease.\n3. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n4. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n5. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n\nCohort 2:\n\nInclusion Criteria:\n\n* Age\n\n  1. Participants must be ≤50 years of age at enrollment.\n\n     Note:\n\n     • Infants and small children are eligible for this study, however, the treating physicians and family must be prepared to deliver adequate local control as required in this study (see BCC Surgical and Imaging Guidelines).\n\n     Diagnosis\n  2. Participants with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site.\n\n     For the purpose of this study, metastatic disease is defined as one or more of the following:\n     * Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases. If there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed.\n     * Contralateral pleural effusion and\u002For contralateral pleural nodules.\n     * Distant lymph node involvement.\n     * Participants with pulmonary nodules are considered to have metastatic disease if the participant has:\n\n       * Solitary nodule ≥0.5 cm or multiple nodules of ≥0.3 cm unless lesion is biopsied and negative for tumor;\n       * Participants with solitary nodule \\\u003C0.5 cm or multiple nodules \\\u003C0.3 cm are not considered to have lung metastasis unless biopsy documents tumor.\n     * Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on H\\&E stains. In the absence of morphologic evidence of marrow involvement on H\\&E, participants with bone marrow involvement detected ONLY by flow cytometry, RT PCR, FISH, or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study.\n\n     For participants that have a positive FDG-PET scan at study enrollment, a bilateral bone marrow biopsy will be required at study entry. If a bone marrow is required, the suggested approach for participants with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy).\n\n     • Bone metastasis: This study utilizes whole body FDG-PET scans to screen participants for bone metastases. Areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or CT (whole body FDG-PET\u002FCT or FDG-PET\u002FMR scan acceptable). Whole body technetium bone scans may be performed at the discretion of the investigator and are not required. For participants without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry.\n\n     Prior Therapy\n  3. Participants must have completed 6 cycles of Induction therapy with VDC\u002FIE per US standard of care (including standard modifications). Participants will enroll after the 6th cycle prior to local control.\n\n     Organ Function Requirements\n  4. Adequate renal function defined as:\n\n     * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n     * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n  5. Adequate liver function defined as:\n\n     * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and\n     * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT \\\u003C 5 times ULN for age).\n  6. Adequate cardiac function defined as:\n\n     * Shortening fraction of ≥27% or\n     * Ejection fraction of ≥50%\n  7. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n  8. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n  9. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n  10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Participants with regional node involvement as their only site of disease beyond the primary tumor.\n5. Participants whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord).\n6. Participants with current CNS disease\n7. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n8. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n\nCohort 3:\n\nInclusion Criteria:\n\n* Age\n\n  1. Participants must be less than 30 years of age at enrollment.\n\n     Diagnosis\n  2. Participants must have histologic diagnosis of osteosarcoma at original diagnosis.\n  3. Participants must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:\n\n     * Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment\\*\n     * Pathologic confirmation of metastases from at least one of the resected sites.\n     * No local recurrence or metastatic disease elsewhere. \\*For participants with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery. No evidence of pulmonary metastatic disease; participants may have no visible lung nodules greater than 3 mm, and not considered to be disease.\n\n     Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, participants will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected. Participants with positive microscopic margins will be eligible to enroll.\n\n     Performance Level\n  4. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n\n     Timing from Prior Therapy\n  5. Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n     * Myelosuppressive anti-cancer therapy: Must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea).\n     * Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.\n     * Radiation therapy (RT): ≥2 weeks for local palliative RT (small port); ≥6 weeks must have elapsed if prior craniospinal RT or if ≥50% radiation of pelvis; ≥6 weeks must have elapsed if other substantial BM radiation.\n     * Surgery: ≥2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies.\n\n     Organ Function Requirements\n  6. Hematological:\n\n     * Platelet count ≥50,000\u002FμL without transfusion in last 7 days\n     * Hgb ≥8.5 without transfusion in last 7 days\n  7. Adequate renal function defined as:\n\n     * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n     * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n  8. Adequate liver function defined as:\n\n     * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age.\n     * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age.\n  9. Adequate cardiac function defined as:\n\n     * Shortening fraction of ≥27%, or\n     * Ejection fraction of ≥50%.\n  10. Adequate pulmonary function defined as:\n\n      o No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry \\>94%.\n  11. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n  12. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Participants with distant bone metastases at original diagnosis or any subsequent relapse (participants with only skip lesions will be eligible).\n5. Participants with concurrent local and pulmonary recurrence at the time of most recent episode of disease recurrence preceding enrollment.\n\n   Note: participants who had local recurrence previously that has been treated and then presented with an isolated pulmonary recurrence and met the surgical resection criteria stated above will be eligible (see IC #3 above).\n6. Participants with primary refractory disease with progression of the primary tumor on initial therapy.\n7. Participants with other sites of extra-pulmonary metastases at the time of any episode of disease recurrence preceding enrollment.\n8. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n9. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.\n\nCohort 4A\u002FB:\n\nInclusion Criteria:\n\nDiagnosis Both Cohorts\n\n1. Participants must have high grade osteosarcoma and received gross total resection prior to start of Cycle 3 MAP therapy. Participants with positive margins are eligible and may receive radiation therapy. This includes secondary malignancies.\n\n   o Note: craniofacial osteosarcoma is NOT permitted.\n2. The primary tumor was resectable after the initial 2 cycles of MAP chemotherapy.\n3. Participants must have had a non-contrast chest CT and primary tumor site imaging consisting of an MRI or CT for optimal visualization of primary tumor site prior to local control. Physical scans and scan reports must be available to submit to BCC.\n\n   Note: Two-view plain radiographs of the primary tumor site can be performed for participants who have a metallic prosthetic implant instead of CT or MRI if a significant metal artifact would occur by those imaging modalities;\n\n   Cohort A only\n4. Participant must have poor response to induction chemotherapy (those with 10% or more viable tumor remaining after surgery) and localized tumor.\n\n   Cohort B only\n5. Have an initial diagnosis of high-grade metastatic extremity or axial osteosarcoma resectable by the treating team.\n\n   o Note: Metastatic pulmonary disease is defined as 3 or more lesions \\>5 mm or 1 lesion \\>1 cm or biopsy proven pulmonary metastatic disease if not meeting these radiographic criteria;\n6. No definite progression of metastatic disease and no evidence of new metastatic disease.\n7. Following definitive primary surgery, complete removal of all metastases or complete removal planned and deemed feasible.\n\n   Non-Diagnostic Inclusion Criteria, Both Cohorts Age\n8. Participants must be ≥5 years and ≤40 years on date of diagnostic biopsy. Performance Level\n9. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60. Participants whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible.\n\n   Prior Therapy\n10. Participants must have completed standard induction therapy for initial diagnosis osteosarcoma (2 cycles \\[10weeks\\]) of MAP, Local control (surgery, assessment of histologic response), and a post-surgery 3rd cycle (5 weeks) of MAP. Participants will enroll after the 3rd cycle of MAP.\n\n    Organ Function Requirements\n11. Participants must have adequate renal function defined:\n\n    * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n    * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n    * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n12. Adequate cardiac function defined as:\n\n    * Shortening fraction of ≥28%, or\n    * Ejection fraction of ≥50%\n13. Adequate liver function defined as:\n\n    * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age\n    * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age.\n14. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n15. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n16. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n5. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.","0 Years","50 Years",{"count":275,"type":20},406,[86],"Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and\u002For maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.",[60,28,227],{"date":280,"type":40},"2026-06-12",{"date":282,"type":40},"2026-06-05",{"date":284,"type":20},"2036-06-01",{"name":97,"class":47},2,{"id":288,"slug":4,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":132,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":19},"100546451","NCT06395103","Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A\u002FLIGHTBEAM-U01)","LIGHTBEAM-U01 Substudy 01A: A Phase 1\u002F2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL\u002FBurkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.\n* For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.\n\nExclusion Criteria:\n\n* History of solid organ transplant.\n* Clinically significant (ie, active) cardiovascular disease.\n* Known history of liver cirrhosis.\n* Ongoing Grade \\>1 peripheral neuropathy.\n* Demyelinating form of Charcot-Marie-Tooth disease.\n* Diagnosed with Down syndrome.\n* Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.\n* History of human immunodeficiency virus (HIV) infection.\n* Contraindication or hypersensitivity to any of the study intervention components.\n* Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.\n* Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).\n* Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and\u002For cytoreductive therapy with steroids\u002Fhydroxyurea.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Known additional malignancy that is progressing or has required active treatment within the past 1 year.\n* Active infection requiring systemic therapy.\n* Known history of Hepatitis B or known active Hepatitis C virus infection.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.",{"count":294,"type":20},90,[85,86],"Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)\u002FBurkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.",[298,299,300,89,28],"B-cell Acute Lymphoblastic Leukemia","Diffuse Large B-cell Lymphoma","Burkitt Lymphoma","2026-06-04",{"date":303,"type":40},"2026-06-08",{"date":305,"type":40},"2024-08-16",{"date":307,"type":20},"2029-03-31",{"name":309,"class":264},"Merck Sharp & Dohme LLC",{"id":311,"slug":4,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":244,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":328,"locationsCount":286},"100607436","NCT07188532","Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial","Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR)","BEAR","Inclusion Criteria:\n\n* Histological confirmation of Ewing sarcoma, including both skeletal and extra-skeletal primary tumors. Patients with \"Ewing-like\" sarcoma may be eligible if patients are planned to be treated per Ewing treatment paradigms, as defined in this clinical trial\n* Patients of age ≥ 2 years are eligible for the study\n* Lansky or Karnofsky performance status ≥ 70\n* Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance\n* Willing to provide blood samples for correlative research purposes\n* Willing to provide biopsy sample to run Mayo Complete Solid Tumor Panel if tumor size is \\>= 8 cm\n\nExclusion Criteria:\n\n* Prior chemotherapy or radiotherapy that, in the opinion of the treating medical oncologist or radiation oncologist, is considered to interfere with the current treatment or measurement of outcomes\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n\n  * Note: Co-enrollment on another clinical trial is allowed per the treating radiation oncologist's discretion\n* Other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n* Patients that have severe co-morbid systemic illness or other disease which would interfere significantly with the current treatment or measurement of outcomes\n* Patients that have active uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness or social situation that would limit study adherence\n* Any of the following:\n\n  * Pregnant patients\n  * Nursing patients",{"count":318,"type":20},141,[23],"This clinical trial evaluates the effect of radiotherapy doses based on tumor size and tumor-specific characteristics (biologically-adapted) in treating patients with Ewing sarcoma. Radiotherapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Conventional radiotherapy uses minimal imaging support to determine the positioning of radiotherapy. Hypofractionated radiotherapy delivers higher doses of radiotherapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Dose-escalated radiotherapy uses doses that are higher than those used in conventional radiotherapy. Larger tumor sizes and other tumor-specific characteristics have been shown to be related to poorer outcomes. In addition, after dose-escalated radiotherapy, patients with larger tumors have demonstrated improved control of the disease at the primary tumor site. Giving biologically-adapted, dose-escalated radiotherapy may reduce the return of the cancer at the primary tumor site in patients with Ewing sarcoma with large tumors and other unfavorable characteristics. This clinical trial also evaluates the role of biomarkers in patients with Ewing sarcoma. Studying samples of blood and tumor tissue from patients with Ewing sarcoma in the laboratory may help doctors learn more about predicting the amount of disease and the likelihood of the cancer coming back.",[28,322],"Round Cell Sarcoma With EWSR1-non-ETS Fusion","2026-06-03",{"date":301,"type":40},{"date":326,"type":40},"2025-11-24",{"date":185,"type":20},{"name":329,"class":47},"Mayo Clinic",{"id":331,"slug":4,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":215,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":74},"100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":20},[338],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[341,342,343,344,345,60,63,28,29,346,347,348,349,350,351],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":282,"type":40},{"date":355,"type":40},"2026-05-01",{"date":357,"type":20},"2028-05-01",{"name":359,"class":47},"University of California, Irvine",{"id":361,"slug":4,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":365,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":369,"conditions":370,"keywords":374,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":390,"locationsCount":392},"100608130","NCT07197554","A Phase 1\u002F1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old.\n* Has a metastatic or locally advanced and unresectable solid tumor.\n* Has at least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* Has an ECOG performance status ≤ 2 at screening.\n* Has adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Has received prior radiotherapy within 2 weeks of treatment.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter.\n* Had major surgery within 28 days before study therapy administration\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy.\n* Has previously received a RBM39 inhibitor\u002Fdegrader.","16 Years",{"count":367,"type":20},171,[85],"A Phase 1\u002F1B Study of ST-01156 in Patients with Advanced Solid Malignancies",[371,28,372,373],"Advanced Solid Tumors","Hepatocellular Carcinoma (HCC)","Biliary Tract Cancer (BTC)",[375,376,377,378,379,32,380,381,382,383,384],"cancer","solid tumors","RBM39","RBM39 degrader","metastatic solid malignancies","Hepatocellular carcinoma","HCC","Biliary tract carcinoma","endometrial carcinoma","Adolescents","2026-05-30",{"date":352,"type":40},{"date":388,"type":40},"2025-12-01",{"date":185,"type":20},{"name":391,"class":264},"SEED Therapeutics, Inc.",6,{"id":394,"slug":4,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":399,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":402,"phases":4,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":74},"100638305","NCT07620431","Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma","An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential Surgery for High-Risk Localized Ewing Sarcoma","Inclusion Criteria:\n\n1. The subject or their legal representative signs the written informed consent prior to enrollment.\n2. Age \\\u003C= 55 years old.\n3. Histologically confirmed Ewing sarcoma, with FET family (including EWSR1 or FUS) gene rearrangement confirmed by FISH or NGS. Clear FET-non ETS fusion cases are excluded.\n4. Deemed difficult to achieve a satisfactory surgical margin by 2 or more senior musculoskeletal oncologists.\n5. ECOG Performance Status: 0-1.\n6. Expected life expectancy \\>= 3 months.\n7. Women of childbearing potential must have a negative pregnancy test within 1 week prior to enrollment and agree to use contraception; male subjects must agree to use contraception or have undergone surgical sterilization during the study.\n\nExclusion Criteria:\n\n1. No opportunity for surgical resection after neoadjuvant chemotherapy.\n2. Extensive metastasis with no indication for local surgical resection.\n3. Uncontrolled concurrent medical conditions.\n4. Prior radiotherapy to the surgical site during front-line treatment.\n5. History of other malignant tumors within the past 5 years.\n6. Inability to cooperate with preoperative neoadjuvant radiotherapy (e.g., due to psychiatric factors).\n7. Any condition that, in the investigator's judgment, might harm the patient or prevent compliance with study requirements.","12 Months",{"count":401,"type":20},55,"OBSERVATIONAL","This is a single-center, single-arm, prospective observational study to evaluate the long-term local control rate, safety, and efficacy of preoperative neoadjuvant radiotherapy (36-45 Gy) followed by sequential radical surgery and postoperative chemotherapy in patients with high-risk, resectable localized Ewing sarcoma.",[28,405],"Bone Neoplasms",[407,408,409,410,411],"Neoadjuvant Radiotherapy","Preoperative Radiotherapy","Observational Study","Local Control Rate","Wound Healing","2026-05-27",{"date":352,"type":40},{"date":205,"type":20},{"date":416,"type":20},"2027-12-01",{"name":418,"class":47},"Peking University People's Hospital",{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":286},"100606238","NCT07172958","Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed\u002FRefractory Embryonal Tumors (SABRE)","Selective Antigen Specific dTβRII-expressing T Cells and B7-H3 CAR T Cells in Subjects With Relapsed\u002FRefractory Embryonal Tumors (SABRE)","SABRE","Inclusion Criteria:\n\nRecipient Inclusion Criteria for Procurement:\n\n* Diagnosis of relapsed\u002Frefractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor\n* Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for their specific tumor type, or unable to receive such therapies due to unacceptable toxicity or contraindication\n* Measurable or evaluable disease by imaging, as determined following most recent therapy\n* Age ≥ 1 year and \\\u003C 24 years\n* Weight \\> 10 kg\n* No systemic steroid exposure within 1 week of procurement\n* Karnofsky\u002FLansky score of ≥ 60 (See Appendix 3)\n* Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure\u002Fs (as described in Appendix 5) during study protocol participation through 6 months following the administration of the CAR-TA T cells\n* ANC \\> 500\u002FµL\n* ALC \\> 1000\u002FµL\n* Platelet count \\> 50,000\u002FuL (level can be achieved with transfusion)\n* Bilirubin ≤ 2.5 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002FAlanine transaminase (ALT) ≤ 5x the upper limit of normal for age\n* Serum creatinine Maximum serum creatinine (mg\u002FdL) Age Male Female\n\n  1. to \\\u003C 2 years 0.6 0.6\n  2. to \\\u003C 6 years 0.8 0.8\n\n  6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.2\n\n  ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m for patients with levels above\n* For FOCBP: Negative pregnancy test\n* Pulse oximetry of \\> 90% on room air\n* Adequate cardiac function defined as: o Shortening fraction of ≥ 27% by echocardiogram, or o Ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram (i.e., MUGA).\n* No acute neurological toxicity \\> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).\n* The following time frames must have elapsed between prior therapy completion and apheresis cell collection:\n\n  * Myelosuppressive chemotherapy\u002Fimmunomodulatory medications: At least 3 weeks, or 6 weeks if prior nitrosourea.\n  * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.\n  * Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen.\n  * Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.\n  * Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved the CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and the patient has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n  * Autologous stem cell transplant\u002Finfusion: At least 6 weeks from their infusion after an autologous stem cell infusion following myeloablative therapy. Patients who received an autologous stem cell infusion following non-myeloablative therapy do not have a wash-out period; they are eligible once they meet all other eligibility requirements, including recovery from acute side effects.\n  * Investigational agent: at least 28 days since receiving an investigational agent.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nRecipient Inclusion Criteria for CAR-TA T cell product Infusion:\n\n* No systemic steroid exposure within 1 week prior to protocol therapy initiation\n* Karnofsky\u002FLansky score of ≥ 60 (See Appendix 3)\n* ANC \\> 750\u002FuL\n* Platelet count \\> 75,000\u002FuL\n* Bilirubin ≤ 2.5 mg\u002FdL\n* AST\u002FALT ≤ 5x the upper limit of normal for age\n* Serum creatinine Maximum serum creatinine (mg\u002FdL) Age Male Female\n\n  1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.2\n\n  ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m for patients with levels above\n* For FOCBP: Negative pregnancy test\n* Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure\u002Fs (as described in Appendix 5) through 6 months following the administration of the CAR-TA T cells\n* Adequate respiratory function defined as oxygen saturation 90% or higher on room air\n* No acute neurological toxicity \\> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).\n* Adequate cardiac function defined as:\n\n  * Shortening fraction of ≥ 27% by echocardiogram, or\n  * Ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram\n* The following time frames must have elapsed between completion of prior therapy and the initiation of SABRE protocol therapy:\n\n  * Myelosuppressive chemotherapy: At least 2 weeks from last dose of chemotherapy.\n  * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.\n  * Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen.\n  * Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.\n  * Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and the patient has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n  * Investigational agent: At least 28 days since receiving an investigational agent.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nExclusion Criteria:\n\nRecipient Procurement Exclusion Criteria:\n\n* Patients with known CNS disease.\n* Patients with uncontrolled infection\u002Fs or known HIV infection\n* Pregnant or lactating females.\n* Patients who have undergone previous allogeneic stem cell transplant.\n\nRecipient Exclusion Criteria for CAR-TA T cell product Infusions:\n\n* Patients with uncontrolled infections or known HIV infection.\n* Pregnant or lactating females\n* Whole lung\u002Fmediastinal radiation within 12 weeks\n* Clinically significant systemic illness or medical condition likely to interfere with assessment of safety or efficacy","23 Years",{"count":428,"type":20},18,[85],"This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed\u002Frefractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor.\n\nPatients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population. Both doses will be based on the recipient's body weight.\n\nThe safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.",[29,28,89,147],[433,434],"CAR T Therapy for Embryonal tumors","T cell Therapy for Embryonal tumors","2026-05-20",{"date":437,"type":40},"2026-05-22",{"date":439,"type":40},"2026-01-27",{"date":441,"type":20},"2038-12",{"name":443,"class":47},"Children's National Research Institute",{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":450,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":21,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":472},"100340699","NCT03715933","Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas","An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas","Inclusion Criteria:\n\n1. Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.\n2. Part 3 combination therapy expansion tumor types:\n\n   * Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.\n   * Colorectal adenocarcinoma: Patients who have failed 1 (one) prior line of systemic therapy that did not include irinotecan.\n   * Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD\u002FTPI-naïve.\n3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.\n4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).\n6. Estimated life expectancy of at least 12 weeks.\n7. Availability of archival tissue or fresh cancer biopsy are mandatory.\n\nExclusion Criteria:\n\n1. Prior treatment with or exposure to DR5 agonists.\n2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.\n3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.\n4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.\n5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.\n6. Prior or concurrent malignancies. Exceptions per protocol.\n7. Hematologic malignancies.\n8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.\n9. Chronic liver diseases including fatty liver. Exception: Patients \\\u003C 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion\u002Fexclusion criteria is confirmed.\n10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.\n11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.\n12. Known sensitivity or contraindications to the following drugs:\n\n    * Ewing sarcoma: irinotecan or TMZ\n    * colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP\u002FTPI\n13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.\n14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.\n15. Major surgery within 4 weeks prior to enrollment on this trial.\n16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.\n17. Other exclusion criteria per protocol.","12 Years","85 Years",{"count":453,"type":20},411,[85],"This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).",[28,457],"Colorectal Adenocarcinoma",[459,460,461,173,462,28,463,464],"Phase 1","Phase 1 Clinical Trial","Solid Tumors","DR5","CRC","colorectal adenocarcinoma",{"date":437,"type":40},{"date":467,"type":40},"2018-10-08",{"date":469,"type":20},"2029-06",{"name":471,"class":264},"Inhibrx Biosciences, Inc",36,{"id":474,"slug":4,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":21,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":74},"100431379","NCT04897321","B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)","Inclusion Criteria:\n\nProcurement and T-cell production eligibility\\*\n\n\\*a previously collected, autologous leukapheresis product can be used for T-cell production\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Rapidly progressive disease (in the opinion of the study PIs)\n\nInclusion criteria\n\nTreatment eligibility\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease\n* Evidence of relapsed or refractory disease after standard first-line therapy\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Echocardiogram with a ventricular ejection fraction\n* \\>40%; or shortening fraction ≥25%\n* Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value\n* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Hemoglobin≥ 7g\u002FdL (can be transfused)\n* Platelet count \\>50,000\u002FuL (can be transfused)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n* Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products\n\nExclusion criteria\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe, uncontrolled intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion\n* Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).\n* Rapidly progressing disease (in the opinion of the study PIs)","21 Years",{"count":480,"type":20},48,[85],"3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed\u002Frefractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors.\n\nPrimary objective\n\nTo determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent\u002Frefractory B7-H3+ solid tumors after lymphodepleting chemotherapy\n\nSecondary objective\n\nTo evaluate the antitumor activity of B7-H3-CAR T cells\n\nExploratory objectives\n\n* To evaluate the tumor environment after treatment with B7-H3-CAR T cells\n* To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells",[484,60,29,89,28,147,485,142,486,144,140,487,347,488,489,63],"Pediatric Solid Tumor","Adrenocortical Cancer","Germ Cell Cancer","Hepatoblastoma","Carcinoma","Malignant Peripheral Nerve Sheath Tumors","2026-05-18",{"date":492,"type":40},"2026-05-19",{"date":494,"type":40},"2022-07-06",{"date":496,"type":20},"2028-03-01",{"name":73,"class":47},{"id":499,"slug":4,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":16,"minAge":244,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":21,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":524},"100523316","NCT06094101","Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)","Prospective Phase I\u002FII Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients With Metastasized Fusion-driven Sarcomas Following Standard Treatment","PerVision","Inclusion Criteria, definition of partial remission plus (PRplus)\n\n* Screening Stage 1:\n\n  * Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR) after local therapy and intensive standard chemotherapy protocols.\n  * Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM (Individualized therapy for relapsed malignancies in childhood), MASTER (Register study Molecularly Aided Stratification for Tumor Eradication) or HEROES-AYA networks (Heterogeneity, evolution and resistance of fusion-driven sarcomas in AYA) or similar evaluation.\n* Screening stage 2:\n\n  * Design and production of the patient-individual vaccine cocktail was successful\n  * Patients have reached a complete or stable partial remission (CR or PR) the end of adjuvant and\u002For maintenance cytotoxic treatment. Cytotoxic treatment as per standard or trial recommendations has been completed. Definition of PRplus: Partial remission(plus) implicates that all remaining tumor residua including all metastases have received local therapy by this time point: Either surgical removal or local irradiation. The assessment of which therapy modality and, in the case of irradiation, which radiation dose is selected, lies with the treating physician. Whether PRplus is achieved will be decided finally by the investigator after review of the patient records.\n\nExclusion Criteria:\n\n* Ejection fraction \\\u003C 25%\n* Creatinine-clearance \\\u003C 40ml\u002Fmin\n* Bilirubin \\> 4mg\u002Fdl\n* Alanine aminotransferase (ALT) \\> 400 units (U)\u002Fl and\u002For aspartate aminotransferase (AST) \\> 400 U\u002Fl\n* Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen\u002Fantibody or nucleic acid tests \\[NAT\\]) and CD4-positive cells \\\u003C 500\u002Fμl. Hepatitis B virus: positive for the presence of hepatitis B virus (positive for hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\]) and hepatitis B NAT test \\> 2000 IU\u002Fml). Hepatitis C virus: positive for heavy chain only antibody \\[HCAb\\] or for nucleic acid amplification testing (NAT). Other infections that, in the opinion of the investigator, do not allow a participation in the study.)\n* Subjects with a known hypersensitivity \u002F allergy to any component of the study drugs.\n* Subjects who have received a live, attenuated vaccine within 28 days prior to the administration of the study drug (only stage 2).\n* Subjects with a prior haematopoietic stem cell transplantation \u002F prior organ transplantation.\n* Patients suffering from other malignancies (with the exception of those with a negligible risk of metastasis or death and treated with curative outcome) within 5 years prior to study start.\n* Current or anticipated need for any of the following medications interfering with T cell function from 14 days before 1st vaccination until 28 days after 1st vaccination: Immunosuppressive agents, which influence functionality and activity of T cells, such as steroids (more than 0,5 mg\u002Fkg body weight prednisolone-equivalent), calcineurin-inhibitors, mofetil mycophenolate, sirolimus, everolimus, and cytotoxic medication. Those drugs should be avoided until 28 days after third\u002Ffinal vaccination but may be given after discussion with the principal investigator. Application of tyrosine kinase inhibitors is permitted during the trial (only stage 2).\n* Significant psychiatric disabilities that, in the judgment of the investigator, do not assure reliable participation in the present study.\n* Uncontrolled seizure disorders (occurrence of at least one generalized seizure in the last 3 months) or severe peripheral neuropathy\u002Fleucoencephalopathy (\\> grade 2 according to NCI CTCAE v5.0 neurotoxicity criteria).\n* Autoimmune disease (e.g. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune dermatitis) requiring immunosuppressive treatment\n* Pregnant females\n* Female subjects of childbearing potential (postmenarcheal, with an intact uterus and at least one ovary, and less than one year postmenopausal) not agreeing to use acceptable method(s) of contraception from 30 days prior to Screening stage 2 visit to 180 days after the last vaccination.\n* Male subjects of reproductive capacity not agreeing to use effective contraception from first vaccination of this study to 180 days after the last vaccination.\n* Not willing and\u002For not able to comply with treatment plan, scheduled visits, laboratory tests, contraceptive guidelines and other study procedures.\n* History of any illness or clinical condition that might confound the results of the study or pose an additional risk in administering study drug to the subject, according to the judgement of the investigator. This may include but is not limited to: history of central nervous system or cardiovascular disease, history of relevant drug allergies, history of psychiatric disorder, history or present of clinically significant pathology.\n* Karnofsky performance status of \\\u003C 70% for subjects ≥ 16 years of age, Lansky performance status of \\\u003C 70% for subjects \\\u003C 16 years of age\n* Participation or intended participation in another clinical phase I or II trial with an investigational drug or product within 28 days prior to enrollment (with the exception to participation of the \"frontline and relapsed rhabdomyosarcoma study\"( (FaR-RMS) after completion of the maintenance therapy (EudraCT-2018-000515-24)). Commonly used drugs as per standard or phase III-trials are permitted.","40 Years",{"count":507,"type":20},30,[85,86],"The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.\n\nThis approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.\n\nIt is an interventional, multicenter, open-label, phase I\u002FII feasibility and early proof of concept study evaluating a personalized peptide vaccine.\n\nPrimary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.",[28,29,138],[512,513,514],"metastasized fusion-driven sarcoma","clinical study","phase I\u002FII","2026-04-28",{"date":517,"type":40},"2026-05-04",{"date":519,"type":40},"2023-09-19",{"date":521,"type":20},"2027-09",{"name":523,"class":47},"University Hospital Tuebingen",4,{"id":526,"slug":4,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":16,"minAge":215,"maxAge":167,"enrollmentInfo":531,"targetDuration":4,"studyType":21,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":48},"100587276","NCT06926283","A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors","A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)","Inclusion Criteria:\n\n1. Those who voluntarily sign the ICF and follow the protocol requirements.\n2. Male or female.\n3. Age: ≥ 18 years and ≤ 75 years.\n4. Expected life expectancy ≥ 6 months.\n5. ECOG performance status score: 0-2.\n6. Patients with various solid tumors who have failed standard treatment, including but not limited to progressive mCRPC.\n7. Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng\u002FdL (≤1.73 nmol\u002FL).\n8. Cohort 1: at least one measurable lesion as defined by RECIST v1.1. Cohort 2: at least one metastatic lesion on CT\u002FMRI, or bone scan imaging at baseline. Patients are assigned to the appropriate cohort as assessed by the investigator, the study procedures in Cohort 1 and Cohort 2 may be performed in parallel and simultaneously, it is not necessary to wait until all procedures in either cohort have been completed before initiating procedures in the other cohort.\n9. Toxicities from prior antitumor therapy must have recovered to Grade ≤ 1 as defined in the NCI-CTCAE v5.0 (except alopecia), or Grade 2 as defined by NCI-CTCAE v5.0, except for toxicity not constituting a safety risk by investigator judgment (eg, Grade 2 peripheral neurotoxicity).\n10. Organ function of the subjects must meet the following requirements:\n\nHematology:\n\n1. ANC ≥ 1.5 × 10\\^9\u002FL (prior use of G-CSF is allowed, but G-CSF use is not allowed within 7 days prior to the screening laboratory tests).\n2. Platelet count ≥100×10\\^9\u002FL (platelet transfusion is not allowed within 7 days before the screening laboratory tests).\n3. HGB ≥ 90 g\u002FL (RBC transfusion or recombinant human erythropoietin use is allowed; RBC transfusion is not allowed within 7 days prior to the screening laboratory tests).\n\nLiver function:\n\n1. Total bilirubin (TBIL) ≤1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤1.5×ULN).\n2. AST and ALT ≤ 3.0 × ULN. For patients with liver metastases, both AST and ALT ≤5×ULN.\n\nRenal function:\n\nCcr ≥ 60 mL\u002Fmin; or creatinine ≤ 1.5 × ULN; urinalysis results show protein urine ≤ 1 +.\n\nFor subjects with urine protein ≥2+ in urinalysis during the screening period, a 24-hour urine protein quantification should be performed, and those with 24-hour urine protein quantification ≤1 g can be enrolled.\n\nCoagulation function:\n\n1. INR≤1.5.\n2. APTT or PT ≤ 1.5 × ULN. LVEF≥50%. 11.Subjects and their spouses agree to use effective instrumental or pharmacologic contraception (excluding safe period contraception) from the time of ICF signing until 6 months after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \\> 10 mg\u002Fday for \\> 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).\n2. Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.\n3. Have received monoclonal antibody treatment within 30 days prior to the first dose.\n4. History of solid organ transplantation.\n5. Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).\n6. Presence of meningeal or brain metastases.\n7. Evidence of cardiovascular risk, including any of the following:\n\n   1. QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula \\[QTcF\\]).\n   2. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.\n   3. Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.\n   4. Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.\n   5. Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg.\n8. Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).\n9. History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.\n10. Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.\n11. Prior history of allergy to any component or excipient of DXC008.\n12. Active hepatitis B with HBV-DNA greater than central upper limit of normal or greater than 1000 copies\u002FmL, active hepatitis C (Hepatitis C virus antibody positive with HCV RNA greater than lower limit of detection value).\n13. Known to be seropositive for the HIV; have active syphilis (only patients with a positive syphilis antibody are eligible for enrollment in the study), possible presence of active tuberculosis (chest imaging within 3 months prior to the first dose indicates active tuberculosis infection).\n14. Patients with active bleeding within 30 days before screening, or, judged by the investigator, to be at risk of massive digestive tract hemorrhage, hemoptysis, etc.; or with hereditary bleeding tendency or coagulation disorder, or bleeding symptoms requiring other medical intervention.\n15. Have experienced serious arterial\u002Fvenous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accident (including transient cerebral ischemic attack), deep venous thrombosis, pulmonary embolism.\n16. Female subjects with positive serum pregnancy test or who are breastfeeding.\n17. Those with active infection requiring drug intervention (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment, uncontrollable pleural effusion, ascites, pericardial effusion requiring repeated drainage.\n18. Have received vaccination with live attenuated vaccine within 28 days prior to the first dose or planned to receive such vaccination during the study period.\n19. Patients with other conditions judged by the investigator that may have adverse effect on the patient's participation in the study.",{"count":532,"type":20},110,[85],"This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.",[536,537,28],"Prostate Cancer","Other Solid Tumors","2026-04-23",{"date":540,"type":40},"2026-04-24",{"date":542,"type":40},"2025-05-15",{"date":544,"type":20},"2030-04",{"name":546,"class":264},"Hangzhou DAC Biotechnology Co., Ltd.",{"id":548,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":549,"targetDuration":4,"studyType":21,"phases":550,"briefSummary":24,"conditions":551,"keywords":552,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":557,"leadSponsor":558,"locationsCount":286},"100577303",{"count":19,"type":20},[23],[26,27,28,29],[31,26,32,29,33,34,35],"2026-04-17",{"date":555,"type":40},"2026-04-20",{"date":42,"type":40},{"date":44,"type":20},{"name":46,"class":47},{"id":560,"slug":4,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":81,"enrollmentInfo":566,"targetDuration":4,"studyType":21,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":74},"100386177","NCT04308330","Vorinostat in Combination With Chemotherapy in Relapsed\u002FRefractory Solid Tumors and CNS Malignancies","A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies","NYMC195","Inclusion Criteria:\n\n* Age: Patients must be less than or equal to 1 year and less than or equal to 30 years of age at initiation of protocol therapy.\n* Diagnosis: Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy.\n* Performance status: Patients over 16 years of age must have a Karnofsky score greater than or equal to 50. Children under 16 years of age must have a Lansky score greater than or equal to 50.\n* Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy that included a treatment cassette of irinotecan and temozolomide in combination.\n\n  * Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of initiation of protocol therapy.\n  * Hematologic growth factor support: Patients may not have received G-CSF within the previous 3 days or peg-filgrastim within the past 7 days.\n  * Biologic anti-neoplastic therapy: At least 21 days or 5 half-lives (whichever is of longer duration) must have elapsed since the last administration of biologic antineoplastic therapy.\n  * Radiation therapy: ≥ 14 days since the last dose of local XRT; ≥ 6 months must have elapsed if prior TBI, craniospinal XRT or ≥ 50% radiation of pelvis; ≥ 6 wks must have elapsed if other substantial BM radiation.\n  * Autologous or allogeneic stem cell transplant: No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment.\n* Organ function:\n\nBone marrow function:\n\n* Peripheral absolute neutrophil count (ANC) greater than or equal to 1000 cells\u002FmcL.\n* Platelet count greater than or equal to100,000\u002FmcL and no platelet transfusion within prior 7 days.\n* Hemoglobin greater than or equal to 8 gm\u002FdL\n* Patients with known bone marrow metastatic disease may enroll on the study if they have a peripheral ANC greater than or equal to 750 cells\u002FmcL. They will not be evaluable for hematologic toxicity.\n\n  \\- Adequate liver function:\n* Total bilirubin less than or equal to 1.5x upper limit of normal (ULN) for age.\n* SGPT (ALT) less than or equal to 5x ULN\n* Serum albumin greater than or equal to 2 gm\u002FdL\n\n  \\- Adequate renal function:\n* Creatinine clearance or glomerular filtration rate \\>70 ml\u002Fmin\u002F1.73 m2 or a serum creatinine based on age and gender as follows:\n\nAge Maximum serum creatinine concentration (mg\u002FdL) Male Female 1-\\\u003C2 years 0.6 0.6 2-\\\u003C6 years 0.8 0.8 6-\\\u003C10 years 1 1 10-\\\u003C13 years 1.2 1.2 13-\\\u003C16 years 1.5 1.4 greater than or equal to 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula to estimate glomerular filtration rates (Schwartz et al. J. Peds. 106; 522. 1985) using child length and stature data from the CDC.\n\n\\- Informed consent: All patients less than 18 years of age must sign a written informed consent. For patients \\\u003C18 years of age, a parent or guardian must sign a written informed consent, unless the patient is an emancipated minor. Childhood assent, when appropriate, should be obtained as well per institutional guidelines.\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding: Women who are pregnant or breast feeding will not be entered on the protocol due to the risks of fetal and teratogenic adverse events with the therapeutic agents used in the protocol therapy.\n* Corticosteroid use: Patients with CNS tumors who have not been on a stable or decreasing dose of corticosteroids for the 7 days prior to the initiation of protocol therapy.\n* Antineoplastic therapy: Patients receiving any other antineoplastic therapy.\n* Medication allergy:\n\nAllergy or intolerance to any of the protocol agents: vincristine, irinotecan, temozolomide, or vorinostat.\n\nAllergy or intolerance to cephalosporins.\n\n* Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving therapy for Clostridium difficile infection.\n* Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment.\n* Children with neurofibromastosis Type 1, if being used for treatment of a low grade glioma.",{"count":507,"type":20},[85],"Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy.\n\nThe goals of this study are:\n\n* To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects;\n* To learn what kind of side effects this four drug combination can cause;\n* To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells;\n* To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.",[28,29,147,89,487,348],"2026-04-10",{"date":572,"type":40},"2026-04-15",{"date":574,"type":40},"2017-03-17",{"date":576,"type":20},"2027-12-31",{"name":578,"class":47},"New York Medical College",{"id":580,"slug":4,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":16,"minAge":584,"maxAge":585,"enrollmentInfo":586,"targetDuration":4,"studyType":21,"phases":588,"briefSummary":589,"conditions":590,"keywords":595,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":606,"locationsCount":74},"100632643","NCT07516353","my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults","Inclusion Criteria:\n\n* Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.\n* Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.\n* Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia\u002FLymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.\n* Patients whose treatment includes alkylators, anthracyclines, and\u002For radiation.\n\nInclusion of Children:\n\n• This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be \\\u003C18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and\u002For those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.\n\nExclusion Criteria:\n\n* Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.\n* Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.\n* Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.\n* We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.","15 Years","24 Years",{"count":587,"type":20},143,[23],"This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).",[173,60,28,29,591,592,16,593,594],"Acute Myeloid Leukemia","Aml","Medulloblastoma","Acute Lymphoblastic Leukemia ,Lymphomas",[596,597,598,599,600,173,60,28,29,591,592,16,593],"Cancer Survivorship","Adolescent and Young Adult Cancer","Late Effects of Cancer Treatment","Hodgkin and mature B-cell Lymphomas","Acute Lymphoblastic Leukemia\u002FLymphoma","2026-03-31",{"date":259,"type":40},{"date":604,"type":20},"2026-08-20",{"date":207,"type":20},{"name":607,"class":47},"Dana-Farber Cancer Institute",{"id":609,"slug":4,"hasResults":11,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":11,"sex":16,"minAge":615,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":21,"phases":618,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":392},"100509838","NCT05918640","Lurbinectedin in FET-Fused Tumors","Lurbinectedin in FET-Fusion Tumors (LIFFT)","LiFFT","Inclusion Criteria:\n\n1. Age ≥ 10 years.\n2. Phase 1: Histological confirmed diagnosis of recurrent or relapsed solid tumor failing primary therapy. Patients must have a known FET fusion (fusion that contains EWSR1, FUS, or TAF15) as documented by next generation sequencing, polymerase chain reaction (PCR) or Fluorescence in situ hybridization (FISH). Patients with a histological diagnosis of Ewing sarcoma with EWS-FLI1 are eligible for dose escalation but not for the exploratory cohort. Please note patients with Ewing sarcoma and alternative FET-ETS fusions (including but not limited to EWS-ERG, EWS-ETV1, EWS-ETV4, EWS-FEV, FUS-ERG, FUS-FEV) are eligible for the exploratory cohort.\n3. Phase 2: Histologically confirmed diagnosis of recurrent or relapsed Ewing sarcoma failing primary therapy with confirmation of EWS-FLI1 fusion and breakpoint by Next generation sequencing or PCR or EWSR1 rearrangement confirmed by FISH and available tissue for central confirmation of EWS-FLI1 fusion and breakpoint.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (age \\>16 years) or Lansky of at least 70 (age \\\u003C16 years).\n5. Disease status (baseline imaging must be performed within 28 days of Day 1 of study treatment):\n\n   1. Phase 1: At least one site of measurable disease on CT or MRI as defined by RECIST 1.1 OR evaluable disease with at least one site of disease that has not been previously radiated\n   2. Phase 2: At least one site of measurable disease on CT or MRI as defined by RECIST 1.1\n6. Meets organ function requirements as outlined below:\n\n   1. Liver:\n\n      Alanine aminotransferase (ALT) ≤ 2.5X upper limit of normal. For the purposes of this study the upper limit of normal for ALT is 45 U\u002FL. Aspartate aminotransferase (AST) ≤ 2.5X upper limit of normal. For the purposes of this study the upper limit of normal for AST is 50 U\u002FL. Total bilirubin ≤ 1.5X institutional upper limit of normal with the exception of patients with Gilbert's syndrome who must have bilirubin \\\u003C3X institutional upper limit of normal.\n   2. Renal:\n\n      Creatinine Calculated creatinine clearance (by the Schwartz equation for patients \\\u003C18 years of age and Cockroft-Gault formula (Appendix B) for patients ≥18 years of age) or radionuclide glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin \u002Fm2 or a serum creatinine less than or equal to the age\u002Fgender valued below:\n\n      Age Maximum Serum Creatinine (mg\u002FdL) Male Female 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n\n      ≥ 16 years 1.7 1.4\n   3. Bone marrow:\n\n      Absolute Neutrophil Count (ANC) ≥ 1,000\u002FµL (\\>one week since last dose of short acting medications (e.g. filgrastim) and \\> two weeks since last dose of long acting medications (e.g. peg-filgrastim)) Platelet Count (PLTs) ≥ 100,000\u002F µL (\\>two weeks since last dose of thrombopoietin receptor agonist such as romiplostim and without platelet transfusion within previous 7 days of screening laboratories) Patients with a history of bone marrow involvement are required to have bilateral bone marrow aspirates and biopsies at baseline. Subjects with bone marrow disease are eligible as long as they meet the hematologic requirements above and are not known to be refractory to red cell or platelet transfusions.\n   4. Muscle: Creatine phosphokinase (CPK) CTCAE 5 Grade ≤ 1,\n   5. Cardiac:\n\n   Creatine phosphokinase CTCAE 5 Grade ≤ l, Left ventricular ejection fraction (LVEF) or shortening fraction (SF) per institutional norm LVEF ≥50% OR SF ≥28%.\n7. Written, voluntary informed consent\n8. Fertile males and females of childbearing potential must agree to use an effective method of birth control from screening, through 7 months after last study drug administration for females and 4 months for males. Women of childbearing potential must have a negative pregnancy test during screening procedures. Effective methods of birth control include: double barrier method (condom, diaphragm), abstinence, an intrauterine device (IUD), levonorgestrol implants, medroxyprogesterone acetate injections, or oral contraception. For those subjects whose preferred and usual lifestyle employs abstinence, refraining from heterosexual intercourse must be practiced during the entire active phase of the trial.\n9. Patients ≥18 years must be willing to undergo tumor biopsy at study entry. Patients with Ewing sarcoma or DSRCT must be willing to undergo biopsy post-treatment. If biopsy is contraindicated, enrollment must be approved by study PI and archival tissue must be available.\n10. Time elapsed from previous therapy:\n\n    1. Must be ≥ 3 weeks for systemic myelosuppressive therapy\n    2. ≥ 2 weeks for local radiation therapy (small field), ≥ 150 days after thyrotropin binding inhibition (TBI), craniospinal external beam radiotherapy (XRT) or radiation to ≥50% of the pelvis\n    3. ≥ 2 weeks for major surgery\n    4. ≥ 2 weeks for monoclonal antibodies and oral kinase inhibitors.\n    5. ≥ 6 weeks for autologous stem cell transplant. 6 months for allogeneic stem cell transplant.\n    6. ≥ 6 weeks for any type of cellular therapy\n11. Patients must be recovered to baseline or Grade ≤1from the acute adverse effects of prior treatments, with the exception of alopecia and decreased deep tendon reflexes.\n\nExclusion Criteria:\n\n1. Prior therapy with trabectedin or lurbinectedin.\n2. Subjects with known brain metastases.\n3. Subjects with a known bleeding diathesis.\n4. Subjects who are pregnant or breastfeeding.\n5. Concurrent therapy:\n\n   1. Patients who are currently receiving an investigational drug or another anticancer agent\n   2. Patients receiving over the counter or herbal supplement with significant potential hepatotoxicity in the opinion of the investigator.\n   3. Patients receiving a medically necessary strong or moderate CYP3A4 inhibitor or inducer within 14 days prior to the first dose of study drug.\n6. Clinically significant, unrelated illness or uncontrolled infection which would, in the opinion of the treating physician, compromise the patient's ability to tolerate the investigational agents or be likely to interfere with the study procedures or results.\n7. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n8. Patients with known active viral hepatitis (i.e. Hepatitis A, B, or C)\n9. Patients with Desmoplastic small round cell tumor (DSRCT) will be excluded from enrollment until at least 3 non-DSRCT patients have been enrolled without dose limiting toxicity.","10 Years",{"count":617,"type":20},63,[85,86],"The purpose of this study is to find out if a drug called lurbinectedin (the \"study drug\") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.",[28,142,621,622],"Pediatric Cancer","Undifferentiated Sarcoma",[624,625,626,627,628,629,630],"Ewing Sarcoma-Friend Leukemia Integration 1 Transcription factor (ESW-FLI1)","Ewing Sarcoma Breakpoint Region 1-Friend Leukemia Integration 1 Transcription factor (EWSR1-FLI1)","Ewing Sarcoma Erythroblast Transformation Specific Related Gene (EWS-ERG)","Ewing Sarcoma Breakpoint Region 1 (EWRS1)","TATA-Box-Binding Protein Associated Factor 15 (TAF15)","Fused Tumors (FET)","Ewing Sarcoma-Wilms' Tumor Gene 1 (EWS-WT1)","2026-03-26",{"date":601,"type":40},{"date":634,"type":40},"2023-07-27",{"date":636,"type":20},"2028-07-30",{"name":638,"class":47},"Children's Hospital of Philadelphia",{"id":640,"slug":4,"hasResults":11,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":11,"sex":16,"minAge":450,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":21,"phases":648,"briefSummary":649,"conditions":650,"keywords":654,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":681},"100366742","NCT04055220","Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","A Multicentre Exploratory Phase II Study Describing the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","REGOSTA","INCLUSION CRITERIA :\n\nI1. Age ≥ 12 years at the day of consenting to the study;\n\nI2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferentiated Pleomorphic Sarcomas (UPS), Leiomyosarcomas (LMS) and Angiosarcomas;\n\nI3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment based on the histological subtype:\n\nFor OS, (excepted head and neck localisations), neoadjuvant and\u002For adjuvant chemotherapy should include methotrexate-based regimen for patients \\\u003C 18 years old; patients ≥ 18 years old may have received either methotrexate-based regimen or anthracycline and cisplatin-based regimen For head and neck OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin, cisplatin or ifosfamide-based regimen.\n\nFor non-OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin and\u002For cisplatin-based regimen.\n\nI4. Recovery to NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug\u002Fprocedure related toxicity (except alopecia, anaemia, and hypothyroidism);\n\nI5. Interval between the last chemotherapy administration and the date of randomisation: at least 4 weeks but no longer than 2 months;\n\nI6. Confirmed complete remission or no evidence of disease (for metastatic disease);\n\nPatients with pulmonary micro nodules can be included provided they do not meet the following criteria:\n\n* At least one lung nodule of 10mm or more\n* And\u002For at least two nodules well limited between 6-9mm\n* And\u002For at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions after pre-operative chemotherapy. If no other metastatic localisation is detected at the initial staging, the patient will be considered as localised disease and eligible for randomisation.\n\nI7. Life expectancy of greater than 12 months;\n\nI8. Karnofsky Performance status ≥70 (patients younger than 18-year old) or ECOG performance status \\\u003C 2 (adult patients) ;\n\nI9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n* Absolute neutrophil count ≥ 1.5 Giga\u002Fl\n* Platelets ≥ 100 Giga\u002Fl\n* Haemoglobin≥ 9 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN\n* Glomerular filtration rate (GFR) ≥30 ml\u002Fmin\u002F1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula\n* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)\n* Bilirubin ≤1.5 X ULN\n* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase \\> 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and\u002For GGT \\\u003C 1.5 x ULN.\n* Lipase ≤1.5 x ULN\n* Spot urine must not show ≥ 1 \"+\"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 \"+\" protein or more, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1000 mg\u002F24 hours\n\nI10. INR\u002FPTT ≤1.5 x ULN; Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR\u002FPTT is stable based on a measurement that is pre-dose as defined by the local standard of care;\n\nI11. Women of childbearing potential and male patients must agree to use adequate contraception (Appendix 4) for the duration of treatment and for 7 months (210 days) in WOCBP or 4 months (120 days) in men sexually active with WOCBP after the last dose of regorafenib;\n\nI12. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization and\u002For urine pregnancy test within 48 hours before the first administration of the study treatment;\n\nI13. Patients, and their parents when applicable, must sign and date an informed consent document indicating that they have been informed of all the pertinent aspects of the trial prior to enrolment;\n\nI14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;\n\nI15. Patients covered by a medical insurance.\n\nI16. Body Surface Area (BSA) ≥ 1.30m² at the time of consenting to the study.\n\nNON-INCLUSION CRITERIA :\n\nE1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor);\n\nE2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcomas and Ewing soft tissue sarcomas) and chordomas;\n\nE3. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization;\n\nE4. Cardiovascular dysfunction:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%,\n* Congestive heart failure ≥ New York Heart Association (NYHA) class 2,\n* Myocardial infarction \\\u003C 6 months prior to first study drug administration,\n* Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),\n* Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration;\n\nE5. Uncontrolled hypertension (systolic blood pressure \\> 150mmHg or diastolic pressure \\> 90 mmHg despite optimal treatment);\n\nE6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration;\n\nE7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration;\n\nE8. Ongoing infection \\> Grade 2 according to NCI-CTCAE v5;\n\nE9. Known history of human immunodeficiency virus (HIV) infection;\n\nNota Bene: Subjects with diagnosed human immunodeficiency virus (HIV) are eligible to participate in the study if they meet the following criteria:\n\n1. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;\n2. No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);\n3. Subjects should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \\\u003C 400 copies\u002FmL prior to enrolment;\n\nE10. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy; Nota Bene: Subjects with a history of hepatitis B or C who have normal alanine aminotransferase (ALT) and are hepatitis B surface antigen negative and\u002For have undetectable HCV RNA are eligible;\n\nE11. Dehydration according to NCI-CTC v5 Grade \\>1;\n\nE12. Difficulties to swallow oral medication and\u002For any mal-absorption condition and\u002For any Gastrointestinal (GI) disease that may significantly alter the absorption of regorafenib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection);\n\nE13. Patients with seizure disorder requiring medication;\n\nE14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;\n\nE15. Known hypersensitivity to the active substance or to any of the excipients;\n\nE16. Pregnant women, women who are likely to become pregnant or are breast-feeding\n\nE17. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n\nE18. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;\n\nE19. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent;\n\nE20. Non-healing wound, non-healing ulcer, or non-healing bone fracture;\n\nE21. Patients with evidence or history of any bleeding diathesis, irrespective of severity;\n\nE22. Any haemorrhage or bleeding event ≥ CTCAE v5 Grade 3 within 4 weeks prior to the first study drug administration;\n\nE23. Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results;\n\nE24. Patients using prohibited concomitant and\u002For concurrent medications (see section \"Prohibited concomitant\u002Fconcurrent treatments);\n\nE25.Patients under tutorship or curatorship.",{"count":647,"type":20},168,[23],"Randomized, non-comparative, multicentre exploratory phase II study.\n\nTwo arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study.\n\nThe comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.",[223,60,28,651,652,346,653],"Chondrosarcoma","Undifferentiated Pleomorphic Sarcoma","Angiosarcoma",[655,656,657,658,659,660,661,662,663,664,665,666,60,667,668,669,670,671],"Maintenance therapy","First line therapy","Regorafenib","Randomization","Double-blinded","Placebo controlled","Relapse-free survival","Time to treatment failure","Overall survival","Quality of life","Compliance","Bone sarcoma","Efficacy","Complete response","Tyrosine kinase inhibitor","Multi-target inhibitor","Safety","2026-02-13",{"date":674,"type":40},"2026-02-17",{"date":676,"type":40},"2020-03-03",{"date":678,"type":20},"2026-10-01",{"name":680,"class":47},"Centre Leon Berard",16,""]