To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer
implantation, followed by concomitant limited field radiation therapy and temozolomide,
followed by dose dense temozolomide and bevacizumab in subjects undergoing initial surgery
for newly-diagnosed high grade glioma.
- Subjects, men and women, must be between ages 18 and 75 years.
- Subjects must have radiographic evidence on cranial magnetic resonance imaging (MRI)
of a single, contrast-enhancing unilateral supratentorial cerebral tumor.
- Surgery is recommended within 4 weeks of the baseline MRI scan.
- Subjects must have a Karnofsky Performance Score of 60 or higher.
- Subjects must have signed an Institutional Review Board (IRB)-approved informed
consent prior to any non-standard of care study procedure or no later than the start
of dose dense temozolomide and bevacizumab..
- Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma.
- Subjects, both men and women, must be willing to avoid pregnancy for up to 2 years
after wafer implantation surgery and be counseled regarding the unknown, and
potentially harmful, risks to the embryo or fetus from participation in this study.
- Subjects who have had prior cytoreductive surgery for high-grade glioma. Subjects who
have had a diagnostic stereotactic biopsy are eligible.
- Subjects with more than one focus of tumor or tumor crossing the midline as assessed
by coronal cranial MRI scan.
- Concomitant significant life-threatening disease from which the subject could
reasonably be expected to die within the first 12 months of the study.
- Known hypersensitivity reactions to temozolomide, nitrosoureas or any other
components of the Gliadel® wafer.
- Prior CNS radiotherapy.
- Subjects who have received any prior chemotherapy for this malignant glioma prior to
the baseline evaluation or subjects who are currently being treated with
- Subjects with fewer than 100,000 platelets per mm3 or fewer than 3.500 leukocytes per
- Liver function tests greater than or equal to 2.5 times the upper limit of normal
(transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase).
- Serum creatinine equal to or greater than 1.5 times the upper limit of normal, blood
urea nitrogen (BUN) equal to or greater than 2.5 times the upper limit of normal.
- Pregnancy, or lactating females or females of childbearing potential not using
- Participation in any other investigational protocol in the prior twelve months for
any type of malignancy.
- Psychological, familial, sociological or geographical conditions which do not permit
adequate medical follow-up and compliance with the study protocol.
- Inadequately controlled hypertension (blood pressure systolic > 150 mmHg or diastolic
> 100 mmHg).
- Unstable angina or history of myocardial infarction within six months prior to
- Evidence of bleeding, diathesis, or coagulopathy. Chronic full-dose anticoagulation
with warfarin is not permitted though subjects may be on low molecular weight heparin
- Serious non-healing wound, ulcer, or bone fracture.