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

NCT ID: NCT04022213

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Desmoplastic Small Round Cell Tumor; Peritoneal Cancer; Peritoneal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently \<500/ul despite use of G-CSF for \>1 week, or if patients experience life threatening febrile neutropenia.

Group Type: EXPERIMENTAL

131 I-omburtamab

Intervention Type: DRUG

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

WAP-IMRT

Intervention Type: 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

Group B

DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR

Group Type: EXPERIMENTAL

131 I-omburtamab

Intervention Type: DRUG

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

Group C

Participants with tumors other than DSRCT and will be enrolled onto an assessment arm to determine eligibility. Immunohistochemistry to assess B7H3 expression will be performed on frozen or paraffin embedded tissue using omburtamab (frozen tissue) or a commercially available anti-B7H3 antibody (if paraffin embedded).

Group Type: EXPERIMENTAL

131 I-omburtamab

Intervention Type: DRUG

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

Interventions

131 I-omburtamab

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

Intervention Type: DRUG

WAP-IMRT

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

Intervention Type: RADIATION

Other Intervention Names

Intensity Modulated Radiation Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Y-mAbs Therapeutics

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Slotkin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

19-182

Identifier Type: -

Identifier Source: org_study_id