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Bevacizumab for Brain Cancer

Phase 1 & 2
Recruiting
Led By John Boockvar, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA)
Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of 0-2)
Must not have
Previous treatment with greater than 2 cycles of Bevacizumab at 10mg/kg (2 IV Infusions)
Women who are pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing if repeated doses of the drug bevacizumab, given through a catheter directly to the brain, are safe and effective in treating patients with recurrent brain tumors.

Who is the study for?
Adults with relapsed or refractory high-grade brain tumors like GBM and AA, who have not had more than two cycles of Bevacizumab treatment. Participants must be able to perform daily activities (Karnofsky performance status ≥70%), have at least one confirmed tumor site, and agree to use contraception during the study.
What is being tested?
The trial is testing repeated doses of intraarterial Bevacizumab for safety and effectiveness in treating recurrent malignant glioma. It aims to see if this method improves survival compared to standard intravenous therapy by delivering the drug directly into arteries supplying the tumor.
What are the potential side effects?
Bevacizumab can cause side effects such as bleeding, high blood pressure, wound healing complications, kidney problems, and may affect fertility. Since it's delivered directly to brain arteries in this trial, there might also be risks specific to that delivery method.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of a specific type of brain tumor that has returned or is not responding to treatment.
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I am mostly independent and can care for myself.
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I am 18 years old or older.
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I have at least one tumor confirmed by biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received more than 2 cycles of Bevacizumab at 10mg/kg.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite overall response rate (CORR)
Progression-free survival (PFS) and overall survival (OS)
Secondary study objectives
The safety of repeated SIACI of mannitol and Bevacizumab at 15mg/kg.

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Group II: Arm 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

Feinstein Institute for Medical ResearchOTHER
21 Previous Clinical Trials
5,618 Total Patients Enrolled
2 Trials studying Glioblastoma
52 Patients Enrolled for Glioblastoma
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,106 Total Patients Enrolled
16 Trials studying Glioblastoma
819 Patients Enrolled for Glioblastoma
John Boockvar, MD3.916 ReviewsPrincipal Investigator - Feinstein Institute for Medical Research
Feinstein Institute for Medical Research
13 Previous Clinical Trials
771 Total Patients Enrolled
11 Trials studying Glioblastoma
730 Patients Enrolled for Glioblastoma
5Patient Review
This neurosurgeon is a true hero and miracle worker.

Media Library

Bevacizumab Clinical Trial Eligibility Overview. Trial Name: NCT01269853 — Phase 1 & 2
Glioblastoma Research Study Groups: Arm 2, Arm 1
Glioblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01269853 — Phase 1 & 2
Bevacizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT01269853 — Phase 1 & 2
~3 spots leftby Oct 2025
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