Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas
NCT ID: NCT02496988
Last Updated: 2015-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2015-07-31
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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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
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
Temozolomide+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat
CIK
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
Interventions
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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
CIK
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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The First People's Hospital of Changzhou
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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GLICIK002
Identifier Type: -
Identifier Source: org_study_id
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