NCT00677716

Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse

Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse. To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	131I-chTNT-1/B MAb (Cotara)	Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-09-01
• Completion: 2011-11-01
• First posted: 2008-05-14
• Last updated: 2014-04-24

Locations

7 sites across 2 countries: United States, India