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NCT Number: NCT04022213

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Desmoplastic Small Round Cell Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Peritoneal Cancer Peritoneal Carcinoma Sarcoma

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

131 I-omburtamab

Drug

Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2

WAP-IMRT

Radiation

Group A participants will receive WAP-IMRT approximately 2-4 weeks after completing IP RIT. A dose of 30 Gy will be delivered in 20 fractions of 1.5 Gy given once daily, 5 days per week over the course of approximately 4 weeks

Other names: Intensity Modulated Radiation Therapy

Primary outcomes

  1. Progression Free Survival/PFS

    Time frame: Up to 2 years after treatment is discontinued

    Progression free survival after RIT + WA-IMRT.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Y-mAbs Therapeutics

Registry information

Official study title

Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2019
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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