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Procedure
Surgical Tissue Flap for Glioblastoma
N/A
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating a surgical technique to improve outcomes for people with newly diagnosed brain tumor.
Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of Grade IV glioblastoma multiforme (GBM) who are candidates for significant tumor resection and have not started chemotherapy or radiation. They must be in good enough health to expect to live at least six more months, able to undergo MRI scans, and meet specific blood test criteria. Women of childbearing age must test negative for pregnancy and agree to birth control; men must also agree to use contraception.
What is being tested?
The study is testing the safety and effectiveness of using a patient's own tissue flap—either temporoparietal fascial (TPF) or pericranial—to bypass the blood-brain barrier after surgical removal of GBM tumors. The goal is to see if this technique can improve survival without disease progression and overall lifespan in patients.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, bleeding, reaction to anesthesia, pain at the graft site, swelling, or issues related to wound healing. Since it's a surgical procedure rather than drug therapy, traditional medication side effects are not applicable.
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
Progression Free Survival (PFS)
Secondary study objectives
Overall Survival (OS)
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
469,128 Total Patients Enrolled
John Boockvar, MDPrincipal InvestigatorFeinstein Institute for Medical Research/Lenox Hill Hospital
13 Previous Clinical Trials
793 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am able to care for myself but may not be able to do active work.I don't have any health conditions that could risk my safety or affect the study.I am currently being treated for an infection.My scans show cancer has spread to multiple areas or the lining of my brain/spine.I am scheduled for surgery to remove a brain tumor suspected to be GBM.My neurosurgeon believes they can remove at least 80% of my tumor.I've been cancer-free for 5 years, or I only had skin, prostate, or cervical cancer treated curatively.I am currently pregnant or breastfeeding.I plan to receive Gliadel wafer treatment during my surgery.I have started treatment for glioblastoma.My surgery confirmed I have Grade IV glioblastoma, and a specific flap procedure is possible.
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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