Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

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.