Peritoneal Cancer Clinical Trial
Official title:
Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor
NCT number | NCT04022213 |
Other study ID # | 19-182 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 15, 2019 |
Est. completion date | July 2024 |
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 | Recruiting |
Enrollment | 55 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility | 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 toxicity should be grade 1 or less per NCI CTC version 5 - Renal, gastrointestinal, and hepatic, toxicities should all be grade 2 of less (per NCI CTC version 5) - History of allergy to mouse proteins - Patients with grade 4 hypersensitivity reaction to radiolabeled iodine |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Y-mAbs Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival/PFS | Progression free survival after RIT + WA-IMRT. | Up to 2 years after treatment is discontinued |
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