Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA

Launched by NORTHWELL HEALTH · Jan 3, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Bevacizumab (also known as Avastin) for patients with relapsed glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), which are aggressive types of brain tumors. The goal is to see if giving Bevacizumab directly into the blood vessels of the brain (a method called super-selective intraarterial cerebral infusion) repeatedly is safe and can help improve the length of time patients live without their disease getting worse, as well as overall survival. Previous studies showed that a single dose of this treatment was safe and effective, so this trial will explore whether repeated doses can provide even more benefits.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of recurrent GBM, AA, or a similar tumor type, along with at least one measurable tumor site. They should also be in decent health, able to carry out daily activities, and agree to use contraception during the trial period. If eligible, participants can expect to receive the treatment in a clinical setting, with regular monitoring for any side effects. This trial is currently recruiting participants, and it aims to potentially change how these treatments are delivered to patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older.
• • Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).
• • 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 70% (or the equivalent ECOG level of 0-2).
• • Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period.
• Exclusion Criteria:
• • Previous treatment with greater than 2 cycles of Bevacizumab at 10mg/kg (2 IV Infusions).
• • Women who are pregnant or lactating.
• • Patients with significant inter-current 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.