Phase I/II Trial of Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed Glioblastoma Multiforme

Date de début de l'étude : 1 février 2013

Criteria for Inclusion: Male or female patients of ≥18 years of age. Patients with documented histologic diagnosis of glioblastoma multiforme (newly diagnosed) Patients must have at least one confirmed and evaluable tumor site.∗ *A confirmed tumor site is one 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 ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months. 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. Criteria for Exclusion: Previous treatment with Bevacizumab. 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.