A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other… (NCT04022213) | Clinical Trial Compass
Active — 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
United States31 participantsStarted 2019-07-15
Plain-language 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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival/PFS
Timeframe: Up to 2 years after treatment is discontinued