Clinical Research Directory

Inclusion Criteria: * 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). Inclusion criteria considered during surgery: * Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM). * TPFF and/or pericranial flap is technically feasible. Exclusion Criteria: * 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. * 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.