Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas

The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.

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.