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Procedure
Surgical Tissue Flap for Glioblastoma
N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trialassesses the safety of a surgical technique for newly diagnosed GBM patients, with the aim of improving survival.
Who is the study for?
This trial is for adults over 18 with newly diagnosed GBM who are expected to live at least 6 months and can have an MRI. They must be able to undergo a specific surgery, use birth control if of reproductive potential, sign consent, have a KPS of 70% or more, and meet certain lab criteria. Pregnant women, those already treated for GBM or with active infections or other significant health risks are excluded.
What is being tested?
The study tests the safety of using one's own tissue (TPF or pericranial flap) surgically placed into the brain after tumor removal in patients with GBM. The goal is to see if this method is safe and might help extend the time without disease progression.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, bleeding, reaction to anesthesia, and issues related to healing at both the donor site and where the tissue is placed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria
Secondary study objectives
Overall Survival (OS)
Progression Free Survival (PFS)
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: Surgical tissue autograft: TPF flap/pericranial flapExperimental Treatment1 Intervention
Use of a pedicled autologous piece of tissue called the temporoparietal fascial (TPF) flap or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients
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Who is running the clinical trial?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,148 Total Patients Enrolled
16 Trials studying Glioblastoma
861 Patients Enrolled for Glioblastoma
John Boockvar, MD3.916 ReviewsPrincipal Investigator - Northwell Health
Northwell Health
13 Previous Clinical Trials
813 Total Patients Enrolled
11 Trials studying Glioblastoma
772 Patients Enrolled for Glioblastoma
5Patient Review
Dr. Boockvar is a life-saver. Quite literally. My brother was diagnosed and in surgery to treat his condition within 24 hours. His bedside manner is comforting, and he is very intelligent. We are grateful to have him in our lives.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have started chemotherapy or radiation treatment for glioblastoma.It is possible to perform TPFF and/or pericranial flap procedure.You plan to use Gliadel® wafer during your surgery.You have signs of cancer spreading to multiple areas or to the covering of the brain and spinal cord.You have a Karnofsky Performance Status (KPS) score of 70 or higher.You had another type of cancer in the past, but it has been at least 5 years since you were treated and it went away. If you had certain types of skin cancer, prostate cancer, or cervical cancer that were treated and went away, you can still participate.You are scheduled to have surgery to remove a known or suspected glioblastoma (GBM).A neurosurgeon has determined that at least 80% of the tumor can be removed during surgery.Your blood test results need to be within certain ranges for white blood cells, platelets, and other substances in your blood.You have a positive test for HIV, or have active hepatitis B or hepatitis C infection.You have been diagnosed with the most severe type of brain tumor called glioblastoma multiforme (GBM).
Research Study Groups:
This trial has the following groups:- Group 1: Surgical tissue autograft: TPF flap/pericranial flap
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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