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

NCT04022213 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 19-182
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

Solid Tumor; Peritoneal Solid Tumor; DSRC; I131-Omburtamab; Memorial Sloan Kettering Cancer Center; 19-182

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival/PFS

  Progression free survival after RIT + WA-IMRT.

  Up to 2 years after treatment is discontinued

Study Arms (3)

Group A

EXPERIMENTAL

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.

Drug: 131 I-omburtamab; Radiation: WAP-IMRT

Group B

EXPERIMENTAL

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

Drug: 131 I-omburtamab

Group C

EXPERIMENTAL

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).

Drug: 131 I-omburtamab

Interventions

131 I-omburtamab DRUG

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

Group A; Group B; Group C

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

Also known as: Intensity Modulated Radiation Therapy

Group A

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Y-mAbs Therapeutics: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Desmoplastic Small Round Cell Tumor

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Emily Slotkin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 15, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)