Clinical Research Directory

Inclusion Criteria: * Subjects with documented histologically confirmed primary grade 4 advanced malignant glioma. * No more than 3 prior relapses or prior systemic treatments. * Recurrent disease documented by MRI after prior therapy. * Must have at least one site of bidimensionally measurable disease: archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment. * Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression. * Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits. * At least 18 years old. * Both men and women must practice adequate contraception. * Informed consent. Exclusion Criteria: * Progressed while on temozolomide. * Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1. * Not recovered from the toxic effects of prior therapy. * Pregnant or breast feeding. * History of diabetes mellitus. * Uncontrolled intercurrent illness. * Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study. * HIV positive. * Diagnosis of another malignancy may exclude subject from study.