NCT04022213

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

Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-07-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2019-07-17
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study