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.