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