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

Completed · Phase 1

Conditions studied: Recurrent Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00509301

Run by

Peregrine Pharmaceuticals

People needed

12

Starts

2006-11-01

Expected to finish

2010-03-01

Last updated by the study team

2011-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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