Cytokine-Induced Killer CellsPhase 1/2NCT02494804
Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas
A Phase 1/2 study testing Temozolomide and CIK in people with Cytokine-Induced Killer Cells and Milignant Gliomas, run by The First People's Hospital of Changzhou.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cytokine-Induced Killer Cells, Milignant Gliomas
- What is being tested?
- Temozolomide and CIK
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas
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.
- Conditions
- Cytokine-Induced Killer Cells, Milignant Gliomas
- Being tested
- Temozolomide, CIK
- Keywords
- Cytokine-Induced Killer Cells, Milignant Gliomas, Temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
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
CIKBiological
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Other | 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 Receives: Drug: Temozolomide |
| Temozolomide+CIK | Other | Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat Receives: Biological: CIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (1)
Adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine-Induced Killer CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494804
- Sponsor's protocol ID
- GLICIK001
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas
- ClinicalTrials.gov ID
- NCT02494804
- Acronym / sponsor ID
- GLICIK001
- Conditions
- Cytokine-Induced Killer Cells, Milignant Gliomas
- Keywords
- Cytokine-Induced Killer Cells, Milignant Gliomas, Temozolomide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Other | Drug: TemozolomideCapsules 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 | Other | Biological: CIKAutologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideCapsules 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 | Drug | Temozolomide |
| CIKThe patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat | Biological | Temozolomide+CIK |
Primary outcome
Overall survival
Time frame: 5 years
1 secondary outcome
Adverse events
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Temozolomide and CIK in people with Cytokine-Induced Killer Cells and Milignant Gliomas, run by The First People's Hospital of Changzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changping Wu, M.D (8651968870978, wcpjjt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.