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

Peritoneal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022213
• Other study ID #: 19-182
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2019
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Emily Slotkin, MD
• Phone: 212-639-8856
• Email: slotkine[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Desmoplastic Small Round Cell Tumor
• Peritoneal Cancer
• Peritoneal Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Y-mAbs Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival/PFS	Progression free survival after RIT + WA-IMRT.	Up to 2 years after treatment is discontinued

External Links

•   Memorial Sloan Kettering Cancer Center