Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temozolomide, CIK.
- Who it may be relevant to
- Registry conditions: Cytokine-Induced Killer Cells, Advanced Milignant Gliomas. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas
Overview
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
- Drug 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 - Biological CIK
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
Primary outcome measures
- Overall survival [Time frame: 5 years]
Secondary outcome measures (1)
- Adverse events [Time frame: 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT02496988 · GLICIK002