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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04022213
Other study ID # 19-182
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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