Subjects with newly diagnosed brain tumors who undergo surgical resection and whose
pathology in the operating room shows a high grade glioma will be eligible.
During a screening visit, the study will be discussed, inform consent discussed and signed,
a medical history will be taken and a physical examination and laboratory tests will be
performed. If these tests are all within acceptable ranges, the subject will be considered
for inclusion on this treatment protocol. If the results of any tests are extremely
different from normal expected values, she/he may not be able to participate.
Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon
will attempt to remove the majority of the tumor in the operating room and will send a
portion of the specimen removed to the pathologist immediately. This is called a "frozen
section". If the pathologist believes that the tumor is a high-grade malignant brain tumor,
then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of
the brain. The remainder of the tumor specimen will be given to the pathologist to review
more closely in the laboratory. If the frozen section does not show that the tumor is a
high-grade malignant brain tumor, the subject will not receive the Gliadel wafers and will
be removed from the study. The surgeon will then discuss with the subject the appropriate
treatment options for the disease he or she has.
During recovery in the hospital, another contrast enhanced MRI will be performed within the
first 72 hours after surgery. This is a standard of care for patients who are not involved
on this protocol as well. The subject will have another contrast enhanced MRI and MRS
performed at the 21st Day after his or her surgery. After Day 21, He or she may begin other
forms of treatment. The last contrast enhanced MRI and MRS assessment will be performed 12
weeks after the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may
be performed subsequently at the discretion of the doctor.
Throughout the course of treatment, clinical data will be collected.
- Male or female patients of >17 years of age.
- Patients with a documented histologic diagnosis of high grade malignant glioma on
intraoperative frozen section or squash preparation.
- Solitary, supratentorial lesions that do not cross the midline
- Patients must have a Karnofsky performance status >=60% (or the equivalent ECOG level
of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of
> three months.
- Patients must have adequate hematologic reserve with WBC>=3000/mm3, absolute
neutrophils >=1500/mm3 and platelets >=100,000/ mm3.
- Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper
limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.
- Patients must agree to use a medically effective method of contraception during and
for a period of three months after the treatment period. A pregnancy test will be
performed on each premenopausal female of childbearing potential immediately prior to
entry into the research study.
- Patients must be able to understand and give written informed consent. Informed
consent must be obtained at the time of patient screening.
- Known hypersensitivity or allergy to BCNU (carmustine) or other components of the
Gliadel® wafer, such as polifeprosan polymer.
- Multifocal CNS disease
- Diagnosis of prior CNS tumor
- Women who are pregnant or lactating.
- Posterior Fossa or Brain stem tumor
- Open communication of the resection cavity with the ventricular system and tumors
that cross the midline.
- Concurrent severe medical (e.g., active infection, acute hepatitis, cardiac
arrhythmia, unstable angina, congestive heart failure, uncontrolled diabetes
mellitus, uncontrolled seizures, pulmonary insufficiency, pulmonary fibrosis,
pulmonary embolus, etc) or psychiatric illness, or abnormal laboratory values that
preclude surgical candidacy or limits expected survival to less than 12 weeks. If in
doubt, contact the Study Principal Investigator.
- Patients with significant intercurrent medical or psychiatric conditions that would
place them at increased risk or affect their ability to receive or comply with
treatment or post-treatment clinical monitoring.