Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM

Prior treatment

• Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.
• Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.

Other illness

• Subject has an active infection requiring treatment.
• Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
• Subject has a history of other malignancy, unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment.
• Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
• Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Other

• Subject, if female, is pregnant or is breast feeding.
• Subject intends to participate in another clinical trial.

• 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.