Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

ConditionsColorectal Carcinoma Endometrial Carcinoma Melanoma Neuroblastoma Ovarian Carcinoma Pancreatic Ductal Adenocarcinoma Recurrent Desmoid Fibromatosis Recurrent Ewing Sarcoma Recurrent Hepatoblastoma Recurrent Hepatocellular Carcinoma Recurrent Malignant Solid Neoplasm Recurrent Non-Hodgkin Lymphoma Recurrent Osteosarcoma Refractory Desmoid Fibromatosis Refractory Ewing Sarcoma Refractory Hepatoblastoma Refractory Hepatocellular Carcinoma Refractory Malignant Solid Neoplasm Refractory Non-Hodgkin Lymphoma Refractory Osteosarcoma Solid Pseudopapillary Neoplasm of the Pancreas Wilms Tumor

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age12-30

SponsorChildren's Oncology Group

About this trial

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.

Eligibility criteria

Qualifiers

PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment

PART B: Patients must be >= 12 months and =< 30 years of age at the time of study enrollment

Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse

PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors

Disqualifiers

Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control

Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid

Patients who are currently receiving another investigational drug are not eligible

Patients who are currently receiving other anti-cancer agents are not eligible

Trial design

Treatments tested in this trial

Biospecimen Collection
Dual X-ray Absorptiometry
Tegavivint
X-Ray Imaging

Treatment groups

147 Participants

are divided into 1 treatment group

Locations

Alabama

Children's Hospital of Alabama35233, Birmingham United States

California

Children's Hospital Los Angeles90027, Los Angeles United States

Children's Hospital of Orange County92868, Orange United States

Lucile Packard Children's Hospital Stanford University94304, Palo Alto United States

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov