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

Last updated: August 20, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Peritoneal Cancer

Malignant Ascites

Treatment

WAP-IMRT

131 I-omburtamab

Clinical Study ID

NCT04022213
19-182
  • Ages > 1
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have the diagnosis of DSRCT confirmed at MSKCC

  • Age >1 year and able to cooperate with radiation safety restrictions during therapyperiod.

  • 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 thepatient'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 theabdomen/pelvic OR have had GTR of this disease at the time of catheter placement

Exclusion

Exclusion Criteria:

  • Prior progression of disease

  • Prior hypothermic intraperitoneal chemotherapy (HIPEC)

  • Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAEversion 5

  • Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCICTCAE version 5)

  • History of allergy to mouse proteins

  • Patients with grade 4 hypersensitivity reaction to radiolabeled iodine

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: WAP-IMRT
Phase: 2
Study Start date:
July 15, 2019
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

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