A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum
NCT04022213 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2025-07-20
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.
Conditions
- Desmoplastic Small Round Cell Tumor
- Peritoneal Cancer
- Peritoneal Carcinoma
Interventions
- DRUG
-
131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
- RADIATION
-
WAP-IMRT
Group A participants will receive WAP-IMRT approximately 2-4 weeks after completing IP RIT. A dose of 30 Gy will be delivered in 20 fractions of 1.5 Gy given once daily, 5 days per week over the course of approximately 4 weeks
Sponsors & Collaborators
-
Y-mAbs Therapeutics
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Emily Slotkin, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-15
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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