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.
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, if female, is pregnant or is breast feeding.
Subject intends to participate in another clinical trial.
Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
Subject has an active infection requiring treatment.
Single group
Laparoscopically harvested omental tissue autograft
Procedure/Surgery1. Standard neurosurgical removal of recurrent GBM, 2. removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically), 3. the omental fat will be transferred and implanted into brain tumor cavity, 4. standard closure of surgical resection cavity.
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).
Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection.
Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days.
Progression Free Survival (PFS)
The proportion of patients who are alive at 6 months from omental implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.
Overall Survival (OS)
OS will be calculated as the time from treatment initiation (omental autograft) to the time of death.
Percent of screen fails
To tabulate the number and % of screen failures and understand the reason for screen failures (omental autograft not viable etc.) will be tabulated and summarized.
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