Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas

The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

Inclusion Criteria:

• 18 Years or Older
• Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
• Karnofsky performance status > 70%
• Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL
• Signed informed consent
• Pathologic confirmation of GBM or AAF
• A negative beta hCG test for women of childbearing potential
• Negative HAMA test

Exclusion Criteria:

• Metastases or Second Primary Cancer
• Iodine allergy
• Inability to tolerate oral intake of Lugol's solution
• HIV Infection
• Positive HAMA test
• Pregnancy
• Uncontrolled Seizures