NCT04022213Active, not recruitingPhase 2
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 · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 15 Jul 2019
- Start date
- 15 Jul 2019
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04022213
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 15 Jul 2019 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior progression of disease
- Prior hypothermic intraperitoneal chemotherapy (HIPEC)
Other illness
- Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAE version 5
- History of allergy to mouse proteins
- Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
Other
- Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCI CTCAE version 5)
Who the study is looking for
- 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
Age in the registry: 1 year to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.