Study on the Drug I131-Omburtamab for Treating Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Abdomen

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04022213

Provider View

This clinical trial is testing a new drug, I131-Omburtamab, to see if it can help prevent or slow down the return of certain cancers in the abdomen. The study will also look at any side effects the drug might cause.

Patient Parameters

Program Overview

The aim of this study is to find out how well the drug I131-Omburtamab works in treating Desmoplastic Small Round Cell Tumors (DSRCT) and other solid tumors in the abdomen. Researchers want to learn about the drug's effects, both good and bad, and how it behaves in the body. I131-Omburtamab is not yet approved by the FDA for treating these types of cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Desmoplastic Small Round Cell Tumors (DSRCT) confirmed at MSKCC.
  • Age over 1 year and able to follow safety guidelines during treatment.
  • Before placing the catheter in the abdomen:
    • At least 1 week since last chemotherapy.
    • At least 2 weeks since last biological therapy.
    • Side effects from previous treatments must be mild or back to normal.
  • After surgery, patients must:
    • Have no clear signs of active cancer in the liver or outside the abdomen/pelvis, or have had complete removal of such cancer during catheter placement.

Exclusion Criteria

  • Previous worsening of the disease.
  • Previous treatment with heated chemotherapy in the abdomen (HIPEC).
  • Severe heart, lung, or nerve side effects (greater than grade 1).
  • Severe kidney, stomach, or liver side effects (greater than grade 2).
  • Allergy to mouse proteins.
  • Severe allergic reaction to radiolabeled iodine.

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