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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 belowSelect...
I haven't had IV chemotherapy in the last 3 weeks or radiation in the last 4 weeks.
Select...
My blood counts are within a healthy range.
Select...
My grade IV brain tumor has come back after being completely removed.
Select...
My diagnosis is glioblastoma.
Select...
I am older than 18 years.
Select...
It has been over four weeks since my last surgery.
Select...
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:Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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 • NCT0203642452%
increased intraocular pressure
26%
worsening of cataract
15%
posterior capsule opacification
11%
vitreous syneresis
7%
epiretinal membrane
7%
vitreous hemorrhage
5%
choroidal detachment
5%
congestive heart failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ozurdex
Bevacizumab
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had IV chemotherapy in the last 3 weeks or radiation in the last 4 weeks.My blood counts are within a healthy range.I am not pregnant or breastfeeding.My grade IV brain tumor has come back after being completely removed.My diagnosis is glioblastoma.I am older than 18 years.It has been over four weeks since my last surgery.I can care for myself and am expected to live for at least three more months.
Research Study Groups:
This trial has the following groups:- Group 1: Intra Arterial Bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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