Actively Recruiting
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
Eligibility Criteria
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.
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
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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
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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