Treatment Of Newly Diagnosed, High-Grade, Malignant Glioma With Polifeprosan 20 Containing Carmustine Implant (Gliadel® Wafer) Using MR Spectroscopy Data As A Primary Indicator Of Therapeutic Response.
- 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.