[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449773":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":178,"centralContacts":182,"locations":189,"responsibleParty":224,"collaborators":227,"id":231,"slug":187,"hasResults":232,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":187,"eligibilityCriteria":236,"healthyVolunteers":232,"sex":237,"minAge":238,"maxAge":187,"enrollmentInfo":239,"targetDuration":187,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":187,"overallStatus":192,"whyStopped":187,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"fullName":5,"class":6},"Ohio State University Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (papaverine, RT, paclitaxel, carboplatin)","EXPERIMENTAL","Patients receive PPV IV or SC over 30 minutes and patients receiving chemoradiation undergo 5 fractions of RT per week for 6 weeks or 5 fractions of hypofractionated RT per week for 3 weeks without chemotherapy. Patients undergoing chemoradiation receive paclitaxel IV and carboplatin IV QW over 1-6 weeks or pemetrexed IV followed by carboplatin IV every 3 weeks during radiation in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 positive disease may also receive durvalumab after completing CRT as considered clinically appropriate by the treating medical oncologist. Patients also undergo PET\u002FCT or CT and brain MRI during screening, and blood sample collection, MRI and CT scans throughout the trial.",[13,14,15,16,17,18,19,20,21,22,23,24],"Drug: Carboplatin","Biological: Durvalumab","Drug: Paclitaxel","Drug: Papaverine","Radiation: Radiation Therapy","Drug: Pemetrexed","Radiation: Hypofractionated Radiation Therapy","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging of the Brain with and without Contrast","Procedure: Biospecimen Collection",[26,51,60,70,81,98,105,113,135,146,161,170],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Carboplatin","Given IV",[9],[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo",{"type":52,"name":53,"description":29,"armGroupLabels":54,"otherNames":55},"BIOLOGICAL","Durvalumab",[9],[56,57,58,59],"Imfinzi","Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer","MEDI-4736","MEDI4736",{"type":27,"name":61,"description":29,"armGroupLabels":62,"otherNames":63},"Paclitaxel",[9],[64,65,66,67,68,69],"Anzatax","Asotax","Bristaxol","Praxel","Taxol","Taxol Konzentrat",{"type":27,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Papaverine","Given IV or SC",[9],[75,76,77,78,79,80],"Cerebid","Cerespan","Pavabid","Pavacap","Pavatym","Robaxapap",{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"RADIATION","Radiation Therapy","Undergo RT",[9],[87,88,89,90,91,92,93,94,95,96,97],"Cancer Radiotherapy","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":27,"name":99,"description":29,"armGroupLabels":100,"otherNames":101},"Pemetrexed",[9],[102,103,104],"MTA","Multitargeted Antifolate","Pemfexy",{"type":82,"name":106,"description":107,"armGroupLabels":108,"otherNames":109},"Hypofractionated Radiation Therapy","Undergo hypofractionated RT",[9],[110,111,112,92],"Hypofractionated","Hypofractionated Radiotherapy","hypofractionation",{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"PROCEDURE","Magnetic Resonance Imaging","Undergo MRI",[9],[119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging","Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","nuclear magnetic resonance imaging","sMRI","Structural MRI",{"type":114,"name":136,"description":137,"armGroupLabels":138,"otherNames":139},"Positron Emission Tomography","Undergo PET\u002FCT",[9],[123,140,141,142,143,144,145],"PET","Pet Scan","Positron emission tomography (procedure)","positron emission tomography scan","Positron-Emission Tomography","PT",{"type":114,"name":147,"description":148,"armGroupLabels":149,"otherNames":150},"Computed Tomography","Undergo PET\u002FCT or CT",[9],[151,152,153,154,155,156,157,158,159,160],"CAT","CAT Scan","Computed Axial Tomography","computerized axial tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT SCAN","tomography",{"type":114,"name":162,"description":163,"armGroupLabels":164,"otherNames":165},"Magnetic Resonance Imaging of the Brain with and without Contrast","Undergo brain MRI",[9],[166,167,168,169],"Brain Magnetic Resonance Imaging with and without Contrast","Brain MRI","Brain MRI with and without Contrast","Head MRI with and without Contrast",{"type":114,"name":171,"description":172,"armGroupLabels":173,"otherNames":174},"Biospecimen Collection","Undergo blood sample collection",[9],[175,176,177],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",[179],{"name":180,"affiliation":5,"role":181},"Jeremey Brownstein, MD","PRINCIPAL_INVESTIGATOR",[183],{"name":184,"role":185,"phone":186,"phoneExt":187,"email":188},"The Ohio State University Comprehensive Cancer Center","CONTACT","800-293-5066",null,"OSUCCCClinicaltrials@osumc.edu",[190,209],{"facility":191,"status":192,"city":193,"state":194,"zip":195,"country":196,"cosmosGeoPoint":197,"geoPoint":202,"contacts":203},"City of Hope","RECRUITING","Duarte","California","91010","United States",{"type":198,"coordinates":199},"Point",[200,201],-117.97729,34.13945,{"lat":201,"lon":200},[204,208],{"name":205,"role":185,"phone":206,"phoneExt":187,"email":207},"Terrence Williams, MD","626-218-5677","terwilliams@coh.org",{"name":205,"role":181,"phone":187,"phoneExt":187,"email":187},{"facility":5,"status":192,"city":210,"state":211,"zip":212,"country":196,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Columbus","Ohio","43210",{"type":198,"coordinates":214},[215,216],-82.99879,39.96118,{"lat":216,"lon":215},[219,222],{"name":220,"role":185,"phone":187,"phoneExt":187,"email":221},"Jeremy M. Brownstein, MD","Jeremy.Brownstein@osumc.edu",{"name":223,"role":181,"phone":187,"phoneExt":187,"email":187},"Jeremy Brownstein, MD",{"type":181,"investigatorFullName":225,"investigatorTitle":226,"investigatorAffiliation":5,"oldNameTitle":187,"oldOrganization":187},"Jeremy Brownstein","Principal Investigator",[228],{"name":229,"class":230},"National Cancer Institute (NCI)","NIH","100449773",false,"NCT05136846","Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer","A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\\\u003C grade 1 (except alopecia) at the time of enrollment\n* Absolute neutrophil count \\>=1.5 x 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Creatinine \\\u003C 1.5 mg\u002FdL or calculated creatinine clearance\\* \\>= 50 mL\u002Fmin or 24-hour urine creatinine clearance \\>= 50 mL\u002Fmin\n\n  * Calculated by the Cockcroft-Gault formula •\\>= 18 years old\n* Non-small cell lung cancer (NSCLC), histologically and\u002For cytologically proven\n* Clinical American Joint Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease.\n\n  * For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive CRT or RT to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic tumor would be considered an additional site of disease with the exception of brain metastases. Up to 10 brain metastases would be considered as 1 site.\n  * Patients with oligometastatic disease will be allowed to receive adjuvant systemic therapy at the discretion of the medical oncologist and additional local therapy to metastatic sites at the discretion of the multidisciplinary team\n* Patients must be considered unresectable or medically-inoperable if stage II-III NSCLC\n\n  * Patients with a local or regional recurrence following surgical resection for whom definitive CRT or RT to disease in the chest is recommended by the multidisciplinary team will be considered eligible\n* Patients must have fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)-computed tomography (CT) scan (or CT chest\u002Fabdomen\u002Fpelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (preferred) or CT scan of the brain with contrast. Non-contrast MRI scans of the chest\u002Fabdomen\u002Fpelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency\n* Patients must have vital signs, history\u002Fphysical examination, laboratory studies (complete blood count \\[CBCP\\] with differential, chemistries including liver function tests, creatinine clearance (CrCl) assessment; pregnancy test if needed within 14 days of registration)\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), glaucoma, or priapism\n* Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment\n* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment\n* Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen\n* Women\u002Fmen of reproductive potential must be counselled on contraception\u002F abstinence while receiving the study treatment\n\n  * Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 6 months after the last dose of radiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration\n* For patients planning to undergo CRT, patient is suitable to receive standard chemotherapy per treating medical oncologist with radiation during study treatment\n\nINCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n•Patients must consent to participate in the main part of this study and be enrolled into the expansion cohort, or consent to participate in the main part of this study and also consent to participate in the optional MRI Imaging study\n\nExclusion Criteria:\n\n* Patients with history of pneumonectomy\n* History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis\n* History of previous radiation therapy which would result in overlapping radiation fields\n* Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST\u002FALT)\n* Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study\n* Any serious and\u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the treating physicians. This could include severe, active co-morbidities such as:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n* Patients who are presently receiving nitrates or nitroglycerin, or have received these medications within 30 days of day 1 of protocol treatment\n* Patients who are currently taking Sildenafil should agree to discontinue use for 2 days prior to initiation of papaverine, during the duration of study, and for 2 days after last dose of papaverine\n\nEXCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n* Any medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, pregnancy, nursing mothers, weight greater than 350 pounds)\n* Severe anxiety\u002Fclaustrophobia related to MR imaging despite medications to relieve anxiety\u002Fclaustrophobia\n* Patients who use supplemental oxygen and are not able to stop their oxygen for up to a few hours at a time, or who use oxygen because they have breathing when they are laying down","ALL","18 Years",{"count":240,"type":241},28,"ESTIMATED","INTERVENTIONAL",[244],"PHASE1","This phase I trial finds out the best dose, possible benefits and\u002For side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.",[247,248,249,250,251,252,253,254,255],"Locally Advanced Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Unresectable Lung Non-Small Cell Carcinoma","2026-06-26",{"date":258,"type":259},"2026-06-30","ACTUAL",{"date":261,"type":259},"2021-12-06",{"date":263,"type":241},"2026-12-31",{"name":5,"class":6},2]