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

This study is currently recruiting participants.
Verified July 2012 by People's Hospital of Guangxi
Sponsor:
Information provided by (Responsible Party):
Guosheng Feng, People's Hospital of Guangxi
ClinicalTrials.gov Identifier:
NCT01481259
First received: November 16, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
 Biological: Autologous cytokine-induced killer cell
Other: Pemetrexed
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by People's Hospital of Guangxi:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Quality-of-life [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481259

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

Locations
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
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

No publications provided

Responsible Party: Guosheng Feng, Professor, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT01481259     History of Changes
Other Study ID Numbers: CIKLC-201004
Study First Received: November 16, 2011
Last Updated: July 2, 2012
Health Authority: China: Ethics Committee

Keywords provided by People's Hospital of Guangxi:
Nonsquamous non-small cell lung cancer
Maintenance therapy
Immunotherapy
Autologous cytokine-induced killer cell
Pemetrexed

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 19, 2013