Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)

INCLUSION

• Male or female patients of greater or equal18 years of age.
• Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA)
• Patients with a histologically confirmed low-grade brain tumor who relapse with an enhancing tumor on MRI can be evaluated for toxicity only.

• 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 three weeks of treatment on this research study.

• Patients must have a Karnofsky performance status greater or equal to 60% (or the equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of greater or equal to three months.
• Patients must be able to understand informed consent. Informed consent must be obtained at the time of patient screening.
• Because of known concerns with Avastin and wound healing, all craniotomy patients are eligible for the treatment if they have had a craniotomy > two weeks prior to IA therapy. Craniotomy after SIACI bevacizumab therapy should wait 4 weeks.
• Pre-enrollment coagulation parameters (PT and PTT) must be less than or equal to1.5X the IUNL.
• Patients must have adequate hematologic reserve with WBC greater than or equal to 2800/mm3, absolute neutrophils greater than or equal to1500/mm3 and platelets greater than or equal to 100,000/ 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.
• No external beam radiation for four weeks prior to treatment under this research protocol.
• No chemotherapy for three weeks prior to treatment under this research protocol.

EXCLUSION:

• Patients previously treated with more than 6 cycles (28 days each) of Bevacizumab at 10/mg/kg.
• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men who decline to use effective contraception during and for a period of three months after the treatment period.
• Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.