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Bevacizumab for Relapsed Glioblastoma and Anaplastic Astrocytoma

This study is testing a new way to give Bevacizumab (Avastin), a drug used for certain brain tumors. Instead of giving it through a vein (intravenously or IV), researchers are giving it directly into the brain's arteries (intraarterial infusion). This method aims to get more of the drug to the tumor, bypassing the blood-brain barrier. The study is for adults aged 18 or older with relapsed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA). Researchers want to see if this repeated direct delivery of Bevacizumab is safe and effective in shrinking tumors or slowing their growth. They will measure how many patients respond to the treatment and how long they live without their cancer getting worse, and overall survival, at 6 months.

Study design
This is an interventional study with two open-label (meaning you and your doctors will know which treatment you are receiving) and non-randomized arms, planning to enroll 54 participants.
What's involved
You would receive a single dose of intraarterial Bevacizumab on Day 0. If your MRI shows the tumor has grown, you may receive repeat doses of intraarterial Bevacizumab.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works at 6 months, including overall response rate, progression-free survival, and overall survival.

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NCT01269853

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Northwell Health
~54 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Bevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite overall response rate (CORR)
Measured over 6 months
+1 more outcome measured

Conditions

Glioblastoma Multiforme
Anaplastic Astrocytoma

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Anaplastic AstrocytomaGlioblastomaMouse Anaplastic Oligoastrocytoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • John Boockvar, MD · PRINCIPAL_INVESTIGATOR · Feinstein Institute for Medical Research

Who to contact

John Boockvar, MD
[email protected]
212-434-3905
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Composite overall response rate (CORR)6 months

    We will determine this composite overall response rate (CORR) through the Response Assessment in Neuro-Oncology (RANO) criteria

  • Progression-free survival (PFS) and overall survival (OS)6 month

    Six-month progression-free survival (PFS) and overall survival (OS) will be assessed by Kaplan-Meier survival analysis, assuming adequate follow-up time