Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Inclusion Criteria

• •Male or female patients of ≥18 years of age.
• •Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)
• •Patients with pathology confirmed histologic EGFR overexpression
• •Patients must have at least one confirmed and evaluable tumor site.∗
• •\*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.
• •Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
• •No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.
• •Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
• •Pre-enrollment chemistry parameters must show: bilirubin\<1.5X the institutional upper limit of normal (IUNL); AST or ALT\<2.5X IUNL and creatinine\<1.5X IUNL.
• •Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
• •Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
• •Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.