NCT00509301

Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

Detailed description

OBJECTIVES: Primary * To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM * To characterize the biodistribution and radiation dosimetry of Cotara® OUTLINE: This is an open-label, dose escalation study of Cotara®. All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.

Conditions

• Recurrent Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	131-I-chTNT-1/B MAB	The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-07-31
• Last updated: 2011-08-05

Locations

4 sites across 1 country: United States