Status:
ACTIVE_NOT_RECRUITING
A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Y-mAbs Therapeutics
Conditions:
Desmoplastic Small Round Cell Tumor
Peritoneal Cancer
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04022213
Start Date
July 15 2019
End Date
July 1 2026
Last Update
July 20 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065