Actively Recruiting
Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier in Human Recurrent Glioblastoma Multiforme
Led by Northwell Health · Updated on 2026-06-01
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of using laparoscopically harvested autologous omental tissue implanted into the surgical cavity of patients with recurrent glioblastoma multiforme (GBM), a type of brain cancer. This phase I, single-center, single-arm, open-label study explores whether this surgical technique, commonly used in head and neck cancer reconstruction, can bypass the blood-brain barrier and improve treatment delivery to the tumor site. The omental tissue's rich blood vessels and immune cell content may enhance healing and immune response in the brain area after tumor removal. Participants will undergo standard surgical removal of recurrent GBM followed by implantation of a piece of omentum harvested laparoscopically from their abdomen into the brain tumor cavity. After the graft placement, the surgical site will be closed normally. The study focuses on monitoring the safety of this procedure and its effects on disease progression, seizures, stroke, infection, and survival outcomes. Participants will be closely monitored for side effects at multiple time points up to 180 days after the surgery, including MRI scans to assess disease progression. Safety assessments include tracking seizures, strokes, infections, and tumor growth. Secondary outcomes include progression-free survival and overall survival over six months. The study lasts up to 24 months to observe long-term effects and screen failure rates.
CONDITIONS
Brief Title
Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Planned resection of known or suspected glioblastoma multiforme (GBM)
- Karnofsky Performance Status (KPS) of 70% or greater
- Life expectancy of at least 6 months as judged by the investigator
- Candidate for at least 80% resection of enhancing tumor region based on pre-operative evaluation
- Able to undergo MRI evaluation
- Laboratory criteria met including white blood count ≥ 3,000/µL, absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobin > 10.0 g/dL
- Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal
- AST and ALT less than 3 times the upper limit of normal
- Blood urea nitrogen (BUN) and creatinine less than 1.5 times the upper limit of normal
- Females of reproductive potential must have a negative pregnancy test and agree to use acceptable birth control
- Able to understand and willing to sign informed consent
- Histologically confirmed recurrent WHO Grade IV GBM during surgery
- Omental graft is technically feasible during surgery
You will not qualify if you...
- Pregnant or breastfeeding females
- Participation in another clinical trial
- Planned treatment with Gliadel wafer at time of surgery
- Active infection requiring treatment
- Radiographic evidence of multifocal disease or leptomeningeal dissemination
- History of other malignancies unless disease-free for at least 5 years, except certain skin or localized cancers
- Known positive test for HIV or active hepatitis B or C infection
- Other significant medical conditions posing risk or interfering with study
- Prior abdominal surgery making omentum removal risky or inadequate
- Severe renal insufficiency making gadolinium MRI contraindicated
- Unable to have MRI scan for any reason
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery and immediate recovery period
Participants undergo standard neurosurgical removal of recurrent glioblastoma multiforme (GBM) followed by implantation of a laparoscopically harvested piece of their own omental tissue into the brain tumor cavity. The surgical site is then closed as usual.
1 surgery visit and several hospital recovery visits within 72 hours
Duration - Up to 6 months after surgery
Participants are monitored for side effects including seizure, stroke, infection, tumor progression, and death after surgery.
Visits at 7 days, 30 days, 60 days, 120 days, and 180 days post-surgery
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
T
Tamika Wong, MPH
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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