Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Desmoplastic Small Round Cell Tumor | Desmoplastic Small Round Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
| Peritoneal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131 I-omburtamab | Drug | — | UNRESOLVED |
| WAP-IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently \<500/ul despite use of G-CSF for \>1 week, or if patients experience life threatening febrile neutropenia.
- interventionNames
- Drug: 131 I-omburtamab
- Radiation: WAP-IMRT
- type
- EXPERIMENTAL
- label
- Group B
- description
- DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR
- interventionNames
- Drug: 131 I-omburtamab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available