Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.

Phase 1

Completed

• Conditions: Glioma; Brain Neoplasm

• Registration Number: NCT00040573
• Lead Sponsor: TransMolecular

Brief Summary

This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

Detailed Description

This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-06-29
• Study First Submitted QC: 2002-07-01
• Study First Posted: 2002-07-02
• Study Completion: 2003-08
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (3)

City of Hope; 🇺🇸 Duarte, California, United States

Saint Louis University; 🇺🇸 St. Louis, Missouri, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States