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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Carcinoma; Peritoneal Cancer; Desmoplastic Small Round Cell Tumor
• Intervention / Treatment: Drug: 131 I-omburtamab; Radiation: WAP-IMRT

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Neeta Pandit-Taskar, MD; Phone Number: 212-639-3046
• Study Contact Backup: Name: Emily Slotkin, MD; Phone Number: 212-639-8856; Email: slotkine@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Emily Slotkin, MD; Phone Number: 212-639-8856

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 toxicity should be grade 1 or less per NCI CTC version 5
• Renal, gastrointestinal, and hepatic, toxicities should all be grade 2 of less (per NCI CTC version 5)
• History of allergy to mouse proteins
• Patients with grade 4 hypersensitivity reaction to radiolabeled iodine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 131 I-omburtamab; Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2; Radiation: 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; Other Names: Intensity Modulated Radiation Therapy
Experimental: 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	Drug: 131 I-omburtamab; Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
Experimental: 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).	Drug: 131 I-omburtamab; Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival/PFS	Progression free survival after RIT + WA-IMRT.	Up to 2 years after treatment is discontinued

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Y-mAbs Therapeutics
• Investigators: Principal Investigator: Emily Slotkin, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Solid Tumor; Peritoneal Solid Tumor; DSRC; I131-Omburtamab; 19-182
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Desmoplastic Small Round Cell Tumor
• Other Study ID Numbers: 19-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No