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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals

Criteria

Inclusion Criteria:

• Histologically confirmed GBM

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

• 18 to 75 years old (inclusive)

• Karnofsky Performance Status ≥ 70 percent

• If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed

• Adequate hematology

• Adequate renal function

• Adequate liver function

Exclusion Criteria:

• Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease

• Bilateral non-contiguous gadolinium enhancing tumor

• Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)

• Known or suspected allergy to study medication or iodine

• Surgical procedure within four weeks of baseline

• More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline

• Radiation therapy within four weeks of baseline

• Investigational agent within last 30 days

• Previous treatment with any chimeric monoclonal antibody

• HIV positive

• Evidence of active hepatitis