Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic
astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of
tumors also exhibits the most aggressive behavior, resulting in median overall survival
durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of
either surgical resection, external beam radiation or both. All patients experience a
recurrence after first-line therapy, so improvements in both first-line and salvage therapy
are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently
used intravenous (IV) therapies even cross the blood brain barrier (BBB). Superselective
Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the
concentration of drug delivered to the brain while sparing the body of systemic side effects.
One currently used drug called, Bevacizumab (Avastin) has been shown to be active in human
brain tumors but its actual CNS penetration is unknown. This phase I clinical research trial
will test the hypothesis that Bevacizumab can be safely used by direct intracranial
superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival
of patients with relapsed/refractory GBM/AA. By achieving the aims of this study we will
determine the toxicity profile and maximum tolerated dose (MTD of SIACI Bevacizumab. We
expect that this project will provide important information regarding the utility of SIACI
Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to
our patients in the near future.