Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
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|ClinicalTrials.gov Identifier: NCT04222309|
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
All participants 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 omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
|Condition or disease||Intervention/treatment||Phase|
|Glioma Glioma, Malignant Glioblastoma Glioblastoma Multiforme Glioblastoma Multiforme of Brain GBM Brain Cancer||Procedure: Laparoscopically harvested omental free flap||Phase 1|
Laparoscopically harvested omental free flaps are commonly used to fill surgical cavities after resection of head and neck cancers. The investigators hypothesize that a laparoscopically harvested omental free flap in 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 free flap with its long vascular pedicle length, wide rotational arc and available surface area 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 omental free makes it an ideal flap 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 blood vessels of the laparoscopically harvested omental free flap 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 omentum will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM.
The investigators aim to prove that this commonly surgical technique for head and neck cancers is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS).
|Study Type :||Interventional|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)|
|Actual Study Start Date :||January 6, 2020|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Laparoscopically harvested omental free flap
Procedure: Laparoscopically harvested omental free flap
Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
- Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria [ Time Frame: Study Day 1-180 ]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, 90 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 [ Time Frame: Time Frame: Study Day 1-180 ]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, 90 days and 180 days.
- Progression Free Survival (PFS) [ Time Frame: 6 months ]The proportion of patients who are alive at 6 months from flap implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.
- Overall Survival (OS) [ Time Frame: 6 months ]OS will be calculated as the time from treatment initiation (flap implantation) to the time of death.
- Percent of screen fails [ Time Frame: Study Day 1 - 24 months ]The number and percent of screen failures with the reason for screen failures (flap not viable etc.) will be tabulated and summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222309
|Contact: John Boockvar, MDfirstname.lastname@example.org|
|Contact: Tamika Wong, MPHemail@example.com|
|United States, New York|
|Lenox Hill Brain Tumor Center||Recruiting|
|New York, New York, United States, 10075|
|Contact: John Boockvar, MD 212-434-3900 firstname.lastname@example.org|
|Contact: Tamika Wong, MPH 212-434-4836 email@example.com|
|Principal Investigator: John Boockvar, MD|
|Sub-Investigator: David Langer, MD|
|Sub-Investigator: Robert Andrews, MD|
|Sub-Investigator: Christopher Filippi, MD|
|Sub-Investigator: Sherese Fralin, MD|
|Sub-Investigator: Tamika Wong, MPH|
|Sub-Investigator: Mona Li|
|Principal Investigator:||John Boockvar, MD||Northwell Health|