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
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2015
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
July 10, 2015
July 1, 2015
13 years
July 8, 2015
July 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
5 years
Secondary Outcomes (1)
Adverse events
4 weeks
Study Arms (2)
Temozolomide
OTHERCapsules 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
OTHERAutologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat
Interventions
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
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2015
First Posted
July 10, 2015
Study Start
July 1, 2015
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2030
Last Updated
July 10, 2015
Record last verified: 2015-07