Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM

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.