NCT01099644

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

Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Y-mAbs Therapeutics · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to test the safety of a new medicine called antibody 8H9 injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is an antibody or protein which binds to certain tumors, including DSCRT. There is a small number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might not benefit from this treatment. The investigators want to find out what effects, good and/or bad, it has. This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at different dose levels. This is the first study using 131I-8H9 in the peritoneum.

Conditions

• Peritoneal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2019-06-11
• Completion: 2019-06-11
• First posted: 2010-04-07
• Last updated: 2023-10-31

Locations

1 site across 1 country: United States