Standard neurosurgical removal of recurrent GBM,
Removal of fat from the abdomen called omentum using a camera (laparoscopically),
Lining the brain tumor cavity with the piece of omentum,
Joining the blood vessels of the omentum to blood vessels in the scalp or neck to ensure that it maintains good blood flow.

Glioma

Glioma, Malignant

Glioblastoma

Glioblastoma Multiforme

Glioblastoma Multiforme of Brain

Brain Cancer

Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Laparoscopically harvested omental free flap

Lenox Hill Brain Tumor Center

Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human 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, 90 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.

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.

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.

OS will be calculated as the time from treatment initiation (flap implantation) to the time of death.

The number and percent of screen failures with the reason for screen failures (flap not viable etc.) will be tabulated and summarized.

John Boockvar, MD Zucker SOM @Hofstra/Northwell

Principal Investigator

Northwell Health

Squamous Cell Carcinoma

Head and Neck Cancer

Resected Head and Neck Cancer

Mucositis

Oral MRX-1024

Standard Fractionation Radiation Therapy

High-Dose Cisplatin Chemotherapy

MRX, Radiation, and Chemotherapy for Patients With Resected Squamous Cell Carcinoma of the Head and Neck

A Phase 1 Study of Oral MRX-1024 in Combination With Standard Fractionation Radiation Therapy and High-Dose Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck Following Surgical Resection

head and neck neoplasms/seizures

Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

MRX, Radiation, and Chemotherapy for Patients With Resected Squamous Cell Carcinoma of the Head and Neck

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