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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients with recurrent GBM

• Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)

• Patients of 18 years of age or older

• Karnofsky Performance Status ≥ 60 at screening

• Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry

Exclusion Criteria:

• Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm

• Patients with diffuse disease

• Patients with known or suspected allergy to study medication or iodine

• Patients who received investigational agents within 30 days prior to baseline

• Patients who received surgical resection within 4 weeks from baseline

• Patients with known HIV or evidence of active hepatitis

• Patients who cannot undergo MRI