New Surgical Technique in Glioblastoma Multiforme Surgery

Eligibility Details: 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.