Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

Study Overview
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Brief Summary
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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.

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

Conditions
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Cytokine-Induced Killer Cells, Advanced Milignant Gliomas

Intervention / Treatment
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* Drug: Temozolomide
* Biological: CIK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Temozolomide<br>Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days | Drug: Temozolomide<br>* Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days<br>|
| Other: Temozolomide+CIK<br>Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat | Biological: CIK<br>* The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytokine-Induced Killer Cells, Milignant Gliomas, Temozolomide