Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First People's Hospital of Changzhou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Temozolomide
DrugCapsules 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
Biological/VaccineThe patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: TemozolomideOther 1 intervention
Group B: Temozolomide+CIKOther 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
Time frame
5 yearsSecondary outcomes
1
Adverse events
Time frame
4 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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