A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas

Trial ID: NCT02494804

Interventional - Phase 1/2 - Not yet recruiting

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 Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.

Conditions

• Cytokine-Induced Killer Cells
• Milignant Gliomas

Interventions

• Temozolomide
• CIK

Eligibility

Inclusion criteria

• Histologically confirmed intracranial Grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma).
• Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered.
• 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.

Sponsor

The First People's Hospital of Changzhou

Source: Clinicaltrials.gov

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