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Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02496988
Recruitment Status : Not yet recruiting
First Posted : July 14, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
The First People's Hospital of Changzhou

Tracking Information
First Submitted Date  ICMJE July 10, 2015
First Posted Date  ICMJE July 14, 2015
Last Update Posted Date July 14, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Overall survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Adverse events [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas
Official Title  ICMJE A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas
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 Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Cytokine-Induced Killer Cells
  • Advanced Milignant Gliomas
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Temozolomide
  • Temozolomide+CIK
    Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat
    Intervention: Biological: CIK
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2030
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jingting Jiang, M.D 8651968870978 wcpjjt@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02496988
Other Study ID Numbers  ICMJE GLICIK002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The First People's Hospital of Changzhou
Study Sponsor  ICMJE The First People's Hospital of Changzhou
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First People's Hospital of Changzhou
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP