Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

Inclusion Criteria

• •1. Subject is a male or female 18 years of age or older.
• •2. Subject is undergoing planned resection of known or suspected GBM.
• •3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
• •4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
• •5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
• •6. Subject must be able to undergo MRI evaluation.
• •7. Subject meets the following laboratory criteria:
• •1. White blood count ≥ 3,000/μL
• •2. Absolute neutrophil count ≥ 1,500/μL
• •3. Platelets ≥ 100,000/μL
• •4. Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)
• •5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
• •6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
• •7. Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
• •8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
• •9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
• •10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).
• •1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).
• •2. TPFF and/or pericranial flap is technically feasible.