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Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01481259
Recruitment Status : Unknown
Verified July 2012 by Guosheng Feng, People's Hospital of Guangxi.
Recruitment status was:  Recruiting
First Posted : November 29, 2011
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Guosheng Feng, People's Hospital of Guangxi

Tracking Information
First Submitted Date  ICMJE November 16, 2011
First Posted Date  ICMJE November 29, 2011
Last Update Posted Date July 3, 2012
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
Progression-free survival [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • Overall survival [ Time Frame: Two years ]
  • Toxicities [ Time Frame: Two years ]
  • Quality-of-life [ Time Frame: Two years ]
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 Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
Official Title  ICMJE Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
Brief Summary Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Biological: Autologous cytokine-induced killer cell
    Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.
  • Other: Pemetrexed
    Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.
Study Arms  ICMJE
  • Experimental: Immunotherapy
    Subjects receive autologous cytokine-induced killer cell infusion every 21 days
    Intervention: Biological: Autologous cytokine-induced killer cell
  • Active Comparator: Pemetrexed
    Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days
    Intervention: Other: Pemetrexed
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically proven nonsquamous non-small cell lung cancer
  • Stage IIIb-IV, according to AJCC 2010 Staging System
  • Disease measurable
  • Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy
  • No chemotherapy or radiotherapy prior to first-line therapy
  • Age between 18-75
  • Performance status <2
  • No congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease
  • No uncontrolled metabolic disease, infection, and neurological disorders
  • No other malignancies
  • Signed study-specific consent form prior to study entry

Exclusion Criteria:

  • Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy
  • Pregnant or lactating women
  • Patient having hepatitis B virus infection, active tuberculosis, or other infectious diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01481259
Other Study ID Numbers  ICMJE CIKLC-201004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guosheng Feng, People's Hospital of Guangxi
Study Sponsor  ICMJE People's Hospital of Guangxi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guosheng Feng, M.D People's Hospital of Guangxi
Study Chair: Hui Lin, M.D People's Hospital of Guangxi
Study Chair: Yuan Liang, M.D Guangxi Department of Public Health
Study Chair: Heming Lu, M.D People's Hospital of Guangxi
PRS Account People's Hospital of Guangxi
Verification Date July 2012

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