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 theInvestigator.

5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidatefor ≥ 80% resection of enhancing region.

6. Subject must be able to undergo MRI evaluation.

7. Subject meets the following laboratory criteria:

8. White blood count ≥ 3,000/μL

9. Absolute neutrophil count ≥ 1,500/μL

10. Platelets ≥ 100,000/μL

11. Hemoglobin > 10.0 g/dL (transfusion and/or ESA allowed)

12. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit ofnormal (ULN)

13. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN

14. Blood urea nitrogen (BUN) and creatinine < 1.5 x ULN

15. Females of reproductive potential must have a negative serum pregnancy test and bewilling to use an acceptable method of birth control.

16. Males of reproductive potential must be willing to use an acceptable method of birthcontrol to ensure effective contraception with partner.

17. Able to understand and willing to sign an institutional review board (IRB)- approvedwritten informed consent document (legally authorized representative permitted).

Inclusion criteria considered during surgery:

1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IVglioblastoma multiforme (GBM).

2. TPFF and/or pericranial flap is technically feasible.

Exclusion Criteria:

1. Subject, if female, is pregnant or is breast feeding.

2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.

3. Subject intends to participate in another clinical trial

4. Subject intends to undergo treatment with the Gliadel® wafer at the time of thissurgery.

5. Subject has an active infection requiring treatment.

6. Subject has radiographic evidence of multi-focal disease or leptomeningealdissemination.

7. Subject has a history of other malignancy, unless the patient has been disease- freefor at least 5 years. Adequately treated basal cell carcinoma or squamous cell skincancer is acceptable regardless of time, as well as localized prostate carcinoma orcervical carcinoma in situ after curative treatment

8. Subject has a known positive test for human immunodeficiency virus infection, oractive hepatitis B or hepatitis C infection.

9. 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 thestudy evaluation, procedures or completion.