A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum
Running, not enrolling · Phase 2
Conditions studied: Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma
In brief
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.
Key facts
- Study ID
- NCT04022213
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 31
- Starts
- 2019-07-15
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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