Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

Inclusion Criteria:

• Male or female patients of ≥18 years of age

• Patients with a documented histologic diagnosis of relapsed or refractoryglioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplasticoligoastrocytoma (AOA)

• 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

• Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥three months.

• No chemotherapy for two weeks prior to treatment under this research protocol and noexternal beam radiation for eight weeks prior to treatment under this researchprotocol

• Patients must have adequate hematologic reserve with WBC≥3000/mm3, absoluteneutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin musthave a platelet count of ≥150,000/ mm3

• Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutionalupper 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 andfor a period of three months after the treatment period. A pregnancy test will beperformed on each premenopausal female of childbearing potential immediately priorto entry into the research study

• Patients must be able to understand and give written informed consent. Informedconsent must be obtained at the time of patient screening

Exclusion Criteria:

• Women who are pregnant or lactating.

• Women of childbearing potential and fertile men will be informed of the potentialunknown risk of conception while participating in this research trial and will beadvised that they must use effective contraception during and for a period of threemonths after the treatment period

• Patients with significant intercurrent medical or psychiatric conditions that wouldplace them at increased risk or affect their ability to receive or comply withtreatment or post-treatment clinical monitoring

• Patients with radiological evidence of leptomeningeal disease

• Patients with history of allergic reaction to CTX

• Patients who completed chemo/RT less than 6 months prior to enrollment

• Patients who have not failed standard Stupp protocol