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).
Subject is a male or female 18 years of age or older.
Subject is undergoing planned resection of known or suspected GBM.
Subject has a Karnofsky Performance Status (KPS) 70% or greater.
Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
Subject, if female, is pregnant or is breast feeding.
Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
Subject intends to participate in another clinical trial
Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
Single group
Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)
Procedure/SurgerySurgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.
Progression Free Survival (PFS)
PFS is defined as time from surgery until first known disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
OS will be calculated as the time from treatment initiation (TPF implantation) to the time of death.
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