Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT01269853

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

Led by Northwell Health · Updated on 2025-04-09

54

Participants Needed

1

Research Sites

887 weeks

Total Duration

On this page

Sponsors

N

Northwell Health

Lead Sponsor

F

Feinstein Institute for Medical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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). The investigators have shown in a previous phase I trial that a single Super-selective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that the investigators seek to test the hypothesis that repeated dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab to improve progression free and overall survival. The investigators expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to the patients in the near future.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older.
  • Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed oligoastrocytoma.
  • At least one biopsy-proven, confirmed, and evaluable tumor site.
  • Karnofsky performance status of 70% or equivalent ECOG level of 0-2.
  • Agreement to use effective contraception during treatment and for three months after treatment.
Not Eligible

You will not qualify if you...

  • Previous treatment with more than 2 cycles of Bevacizumab at 10mg/kg (2 intravenous infusions).
  • Women who are pregnant or lactating.
  • Significant inter-current medical or psychiatric conditions increasing risk or affecting ability to comply with treatment or monitoring.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lenox Hill Brain Tumor Center

New York, New York, United States, 10065

Actively Recruiting

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Research Team

J

John Boockvar, MD

CONTACT

T

Tamika Wong, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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