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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: Autologous cytokine-induced killer cell Other: Pemetrexed Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
Study Start Date : January 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Immunotherapy
Subjects receive autologous cytokine-induced killer cell infusion every 21 days
 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.
Active Comparator: Pemetrexed
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days
 Other: Pemetrexed
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Two years ]
  2. Toxicities [ Time Frame: Two years ]
  3. Quality-of-life [ Time Frame: Two years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481259


Contacts
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Contact: Heming Lu, M.D 86-771-218-6503 luhming3632@163.com

Locations
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China, Guangxi
Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
People's Hospital of Guangxi
Investigators
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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
More Information
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Responsible Party: Guosheng Feng, Professor, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT01481259    
Other Study ID Numbers: CIKLC-201004
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: July 2012
Keywords provided by Guosheng Feng, People's Hospital of Guangxi:
Nonsquamous non-small cell lung cancer
Maintenance therapy
Immunotherapy
Autologous cytokine-induced killer cell
Pemetrexed
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors