Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT04022213

A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

Conditions: Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma

Sex: All
Ages: 1 Year – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 31
Sponsor: Memorial Sloan Kettering Cancer Center

Location: Memorial Sloan Kettering Cancer Center New York New York

Summary

The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab. 131I-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. Researchers hope to learn more about how 131I-omburtamab works in the body, and how effective it is in treating cancer. 131I-Omburtamab is not approved by the FDA to treat DSRCT or other cancers of the peritoneum.

Eligibility Criteria

Inclusion Criteria: * Have the diagnosis of DSRCT confirmed at MSKCC * Age \>1 year and able to cooperate with radiation safety restrictions during therapy period. * Prior to intraperitoneal catheter placement * At least 1 weeks must have elapsed since prior chemotherapy * At least 2 weeks must have elapsed since biologic therapy * Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline At the completion of surgery, patients must fulfill all of the additional following criteria: * Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement Exclusion Criteria: * Prior progression of disease * Prior hypothermic intraperitoneal chemotherapy (HIPEC) * Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAE version 5 * Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCI CTCAE version 5) * History of allergy to mouse proteins * Patients with grade 4 hypersensitivity reaction to radiolabeled iodine

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04022213). StuddyBuddy aggregates publicly available trial information.