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Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum

NCT01099644 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-10-31

No results posted yet for this study

Summary

A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients \>1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.

Conditions

  • Peritoneal Cancer

Interventions

BIOLOGICAL

131 I-8H9

Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible.

Sponsors & Collaborators

  • Y-mAbs Therapeutics

    lead INDUSTRY

Principal Investigators

  • Shakeel Modak, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2019-06-11
Completion
2019-06-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099644 on ClinicalTrials.gov