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Use of a pedicled autologous piece of tissue called the temporoparietal fascial (TPF) flap or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients

Surgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.

Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)

John Boockvar, MD

Tamika Wong, MPH

David Langer, MD

Netanel Ben-Shalom, MD

Randy D'Amico, MD

Deborah Gruber, MD

Avraham Zlochower, MD

Vadim Zhigin, PA

Olivia Albers, NP

Amy McKewon, NP

This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.

The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).

Glioblastoma (GBM) is the most common primary central nervous system malignancy in adults, and accounts for over half of all malignant brain tumors. The prognosis for newly diagnosed GBM is extremely poor even with Stupp protocol consisting of surgery followed by temozolomide and radiotherapy. For newly diagnosed GBM the median overall survival (OS) is only 15 months, and the median progression-free survival (PFS) is a mere 5-6 months with only 53.9% of patients having 6 month PFS.

This Phase 2 study is an extension of our recently completely enrolled Phase I trial which showed the initial safety of a TPF into the resection cavity of newly diagnosed GBM. All 36 subjects included in this Phase 2 study will initially undergo standard surgical resection for newly diagnosed GBM. Following the resection, the surgical cavity will be lined with a long pedicled, autologous piece of tissue called a temporoparietal fascial flap or pericranium. The patient's dura, bone and scalp will be closed as is customary. The subject will be followed for side effects at 72 hours, 7 days, 30 days, 60 days, 120 days and 180 days. The primary outcome measure will be progression free survival (PFS) and secondary outcome measures will include overall survival (OS). Risk assessment will include seizure, stroke, infection, tumor progression, and death.

Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)

PFS is defined as time from surgery until first known disease progression or death from any cause, whichever occurs first.

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

Northwell Health

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma	NCT05954858	Glioma, Maligna... Glioblastoma Glioblastoma Mu... Glioblastoma Mu... High Grade Glio... GBM Brain Cancer	Tissue autograf...	18 Years -	Northwell Health
Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma	NCT05954858	Glioma, Maligna... Glioblastoma Glioblastoma Mu... Glioblastoma Mu... High Grade Glio... GBM Brain Cancer	Tissue autograf...	18 Years -	Northwell Health

Spots Global Cancer Trial Database for pedicled temporoparietal fascial