Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)
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.
• Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
• Subject must be able to undergo MRI evaluation.
• Subject meets the following laboratory criteria:
∙ White blood count ≥ 3,000/μL
‣ Absolute neutrophil count ≥ 1,500/μL
‣ Platelets ≥ 100,000/μL
‣ Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)
‣ Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
‣ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
‣ Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
• Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
• Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
⁃ Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).
• Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).
• TPFF and/or pericranial flap is technically feasible.