Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Weill Medical College of Cornell University
With
Eisai Inc.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme.
