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A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

Recruiting
1 years of age
Both
Phase 2

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Overview

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.

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

Study details

Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma

NCT04022213

Memorial Sloan Kettering Cancer Center

25 January 2024

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