Cytokine-Induced Killer Cells, Advanced Milignant Gliomas
Conditions
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 Advanced 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
Sponsors
The First People's Hospital of Changzhou
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | 4 weeks |
Contacts
Primary ContactJingting Jiang, M.D
Outcome results
None listed