Actively Recruiting
Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma
Led by Northwell Health · Updated on 2024-09-19
32
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients. The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).
CONDITIONS
Official Title
Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Undergoing planned surgery to remove known or suspected glioblastoma multiforme
- Karnofsky Performance Status of 70% or greater
- Life expectancy of at least 6 months as judged by the investigator
- Candidate for at least 80% tumor resection based on neurosurgeon evaluation
- Able to undergo MRI evaluation
- Meets specific laboratory criteria for blood counts and organ function
- Females of reproductive potential must have a negative pregnancy test and agree to birth control
- Males of reproductive potential must agree to use birth control
- Able to understand and willing to sign informed consent
- During surgery, histologically confirmed WHO Grade IV glioblastoma multiforme
- Temporoparietal fascial flap or pericranial flap is technically feasible during surgery
You will not qualify if you...
- Female who is pregnant or breastfeeding
- Already started chemotherapy or radiation treatment for glioblastoma
- Planning to participate in another clinical trial
- Planning to receive Gliadel wafer treatment at surgery
- Has an active infection requiring treatment
- Evidence of multifocal disease or leptomeningeal spread on imaging
- History of other malignancy within 5 years except certain skin or localized cancers
- Known positive test for HIV or active hepatitis B or C infection
- Any other significant medical condition that poses safety risk or interferes with study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10075
Actively Recruiting
Research Team
J
John Boockvar, MD
CONTACT
T
Tamika Wong, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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