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

NCT04022213 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	31
Start date	2019-07-15
Completion	2026-07

Conditions

• Desmoplastic Small Round Cell Tumor
• Peritoneal Cancer
• Peritoneal Carcinoma

Interventions

• 131 I-omburtamab
• WAP-IMRT

Primary outcomes

• Progression Free Survival/PFS — Up to 2 years after treatment is discontinued
  Progression free survival after RIT + WA-IMRT.

Countries

United States