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Monoclonal Antibodies

Bevacizumab for Glioblastoma

Phase 1
Recruiting
Research Sponsored by Global Neurosciences Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No IV chemotherapy for three weeks prior to treatment under this research protocol and no external beam radiation for four weeks prior to treatment under this research protocol
Patients must have adequate hematologic reserve
Must not have
Women who are pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to give chemotherapy to people with a certain type of brain tumor. The hope is that it will help them live longer.

Who is the study for?
Adults over 18 with a specific brain cancer called Glioblastoma Multiforme that has come back after surgery can join. They should be in good enough health to understand the study and give consent, have normal blood clotting, not have had recent chemotherapy or radiation, and agree to use birth control.
What is being tested?
The trial is testing Bevacizumab delivered directly to the brain tumor through an artery. This method aims to increase drug concentration at the tumor site while reducing whole-body side effects by using a catheter from the leg artery up into the brain.
What are the potential side effects?
Bevacizumab may cause bleeding, high blood pressure, tiredness, headaches, and wound healing problems. The direct infusion technique might reduce these systemic side effects but could include risks associated with catheter placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had IV chemotherapy in the last 3 weeks or radiation in the last 4 weeks.
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My blood counts are within a healthy range.
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My grade IV brain tumor has come back after being completely removed.
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My diagnosis is glioblastoma.
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I am older than 18 years.
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It has been over four weeks since my last surgery.
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I can care for myself and am expected to live for at least three more months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Adverse Events as a Measure of Safety

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
vitreous syneresis
9%
posterior capsule opacification
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intra Arterial BevacizumabExperimental Treatment1 Intervention
Repeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

Global Neurosciences InstituteLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02285959 — Phase 1
Glioblastoma Research Study Groups: Intra Arterial Bevacizumab
Glioblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02285959 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02285959 — Phase 1
~1 spots leftby Jun 2025
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