An interventional study of Laparoscopically harvested omental tissue autograft in Glioma, Glioma, Malignant and Glioblastoma, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
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.
Laparoscopically harvested omental grafts are commonly used to fill surgical cavities after resection of head and neck cancers. Investigators hypothesize that an omental tissue graft implanted into our patients with resected recurrent GBM may be used as a readily available and accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The laparoscopically harvested omental graft omentum would easily conform to many resected GBM cavities in our human patients with acceptable risk. The predictable and rich vascular anatomy of a laparoscopically harvested piece of omentum makes it an ideal tissue for cases of previously irradiated and/or infected wound beds. This is why it is successfully used in head and neck and skull base tumors. The permeability of the new blood vessels formed between the omental graft and the cortical brain surface should allow for improved delivery of chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the tumor (BAT). Milky spots within the greater omentum are very small white-coloured areas of lymphoid tissue will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM. The milky spots are made up of mesenchymal cells and are covered in a layer of mesothelium. These structures surround the small blood vessels. The enclosing mesothelium contains macrophages, lymphocytes and mast cells. They are also known as secondary lymphoid organs. Most milky spots contain extremely thin-walled lymphatic capillaries. In addition, the technique of fat grafting has been reliably used since 1990 as a way to improve and enhance wound healing, scar healing, as well as tissue augmentation and tissue repair following radiation injury.
All subjects included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested piece of autologous omentum. The patient's dura, bone and scalp will be closed as is customary. The subject will be followed for side effects within 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
The investigators aim to prove that this commonly surgical technique for head and neck cancers and reconstructive surgery is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS) and overall survival (OS).
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Inclusion Criteria:
Subject meets the following laboratory criteria:
Inclusion criteria considered during surgery:
Exclusion Criteria:
Use of laparoscopically harvested omental autografts into the resection cavity of recurrent glioblastoma multiforme (rGBM) patients.
Procedure: Laparoscopically harvested omental tissue autograft
1. 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.
Time frame: Study Day 1 - Day 180
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.
Time frame: Study Day 1 - Day 180
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.
Time frame: 6 months
Overall Survival (OS)
OS will be calculated as the time from treatment initiation (omental autograft) to the time of death.
Time frame: 6 months
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.
Time frame: Study Day 1 - 24 Months
Plan to share: No
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