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

Phase 2

Recruiting

• Conditions: Desmoplastic Small Round Cell Tumor; Peritoneal Cancer; Peritoneal Carcinoma

• Registration Number: NCT04022213
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-7-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival/PFS