Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas

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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02494804

Enrollment

Registered

2015-07-10

Start date

2015-07-31

Completion date

2030-07-31

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytokine-Induced Killer Cells, Milignant Gliomas

Keywords

Cytokine-Induced Killer Cells, Milignant Gliomas, Temozolomide

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

Interventions

DRUGTemozolomide

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

BIOLOGICALCIK

The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall survival	5 years

Secondary

Measure	Time frame
Adverse events	4 weeks

Contacts

Primary ContactChangping Wu, M.D

wcpjjt@163.com8651968870978

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026