Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

Phase 4

Not yet recruiting

• Conditions: Cytokine-Induced Killer Cells; Advanced Milignant Gliomas
• Interventions: Biological: CIK; Drug: Temozolomide

• Registration Number: NCT02496988
• Lead Sponsor: The First People's Hospital of Changzhou

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-13
• Last Update Submitted: 2015-07-13
• Study First Posted: 2015-07-14
• Last Update Posted: 2015-07-14
• Primary Completion: 2028-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temozolomide+CIK	CIK	Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat
Temozolomide	Temozolomide	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

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Secondary Outcome Measures

Name	Time	Method
Adverse events	4 weeks