Actively Recruiting
Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
Led by Northwell Health · Updated on 2024-09-19
10
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 I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
CONDITIONS
Official Title
Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is a male or female 18 years of age or older.
- Subject is undergoing planned resection of known or suspected GBM.
- Subject has a Karnofsky Performance Status (KPS) 70% or greater.
- Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
- Subject is a candidate for �3e= 80% resection of enhancing region based on pre-operative evaluation.
- Subject must be able to undergo MRI evaluation.
- Subject meets laboratory criteria including specific minimum blood counts and organ function levels.
- Females of reproductive potential must have a negative pregnancy test and use acceptable birth control.
- Able to understand and willing to sign informed consent.
- Subject has histologically confirmed recurrent WHO Grade IV glioblastoma multiforme during surgery.
- Omental graft is technically feasible during surgery.
You will not qualify if you...
- Female subjects who are pregnant or breastfeeding.
- Subject plans to participate in another clinical trial.
- Subject plans to undergo treatment with Gliadel wafer at surgery.
- Subject has an active infection requiring treatment.
- Radiographic evidence of multi-focal disease or leptomeningeal dissemination.
- History of other malignancy unless disease-free for at least 5 years, with exceptions.
- Known positive test for HIV, or active hepatitis B or C infection.
- Any other clinically significant disorder posing risk or interfering with study.
- Prior abdominal surgery.
- Severe renal insufficiency making gadolinium MRI contraindicated.
- Unable to have MRI scan for any reason.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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