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Monoclonal Antibodies
SIACI Bevacizumab + Temozolomide and Radiation for Glioblastoma
Phase 3
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
Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control
Subject has a Karnofsky Performance Status (KPS) 70% or greater
Must not have
Subject, if female, is pregnant or is breastfeeding
Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 62 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a new treatment for aggressive brain cancer by using Mannitol to open the brain's barrier and then delivering Bevacizumab directly into the brain's arteries. It aims to improve survival rates for patients with newly diagnosed Glioblastoma Multiforme. Bevacizumab, typically administered intravenously, has shown superior outcomes when delivered directly into the brain's arteries in patients with recurrent Glioblastoma Multiforme.
Who is the study for?
This trial is for adults over 18 with newly diagnosed GBM brain cancer, expected to live at least 6 months. They must be able to have an MRI, use birth control if of reproductive potential, and sign consent. Participants need normal blood counts and organ function, a specific diagnosis of GBM per WHO criteria, and a Karnofsky Performance Status of 70% or higher.
What is being tested?
The study compares two treatments for GBM: one group receives standard Temozolomide with Radiation; the other gets an additional treatment called SIACI Bevacizumab (Avastin) alongside Temozolomide and Radiation. The goal is to see if SIACI increases survival without disease progression or overall lifespan compared to the standard therapy.
What are the potential side effects?
Potential side effects include complications from intraarterial infusion like stroke or bleeding in the brain, as well as those associated with Bevacizumab such as high blood pressure, bleeding problems, wound healing complications, kidney issues and immune reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and agree to use birth control.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
My brain tumor is confirmed as GBM, IDH-wild type, according to 2021 WHO standards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
Select...
I have started treatment for glioblastoma.
Select...
My scans show cancer has spread to multiple areas or the lining of my brain/spine.
Select...
I am currently being treated for an infection.
Select...
I don't have any health conditions that could risk my safety or affect the study.
Select...
My brain tumor is not a glioblastoma but has an IDH mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 62 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~62 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Secondary study objectives
Progression-free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SIACI of Bevacizumab (Avastin) with Temozolomide and RadiationExperimental Treatment1 Intervention
Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation
Group II: Standard of care Temozolomide and RadiationActive Control1 Intervention
Standard of care Temozolomide and Radiation
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Glioblastoma (GBM) is a highly aggressive brain tumor with poor prognosis. Common treatments include surgery, radiation therapy, and chemotherapy.
Bevacizumab, an anti-angiogenic agent, is used to inhibit the growth of blood vessels that supply the tumor, thereby starving it of nutrients and slowing its growth. The Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab aims to deliver the drug directly to the tumor site, potentially increasing its efficacy and reducing systemic side effects.
This targeted approach is crucial for GBM patients as it may improve survival rates and quality of life by more effectively controlling tumor growth and minimizing adverse effects.
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
468,702 Total Patients Enrolled
16 Trials studying Glioblastoma
441 Patients Enrolled for Glioblastoma
John Boockvar, MDPrincipal InvestigatorFeinstein Institute for Medical Research/Lenox Hill Hospital
13 Previous Clinical Trials
393 Total Patients Enrolled
11 Trials studying Glioblastoma
352 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and agree to use birth control.I am currently pregnant or breastfeeding.I am mostly able to care for myself and carry out daily activities.My brain tumor is confirmed as GBM, IDH-wild type, according to 2021 WHO standards.I am willing to use birth control.I have started treatment for glioblastoma.My scans show cancer has spread to multiple areas or the lining of my brain/spine.I am currently being treated for an infection.I am 18 years old or older.I have had cancer before, but it meets certain conditions.I don't have any health conditions that could risk my safety or affect the study.My brain tumor is not a glioblastoma but has an IDH mutation.
Research Study Groups:
This trial has the following groups:- Group 1: SIACI of Bevacizumab (Avastin) with Temozolomide and Radiation
- Group 2: Standard of care Temozolomide and Radiation
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Glioblastoma Patient Testimony for trial: Trial Name: NCT05271240 — Phase 3