Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
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:
NCT01592422
First received: April 26, 2012
Last updated: July 2, 2012
Last verified: July 2012

April 26, 2012
July 2, 2012
July 2012
July 2015   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01592422 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Quality-of-life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not been confirmed. Many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a 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 randomized controlled study was conducted to compare CIK cells with best supportive care as maintenance therapy for SCLC.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Biological: Autologous cytokine-induced killer cell
    Subjects receive autologous cytokine-induced killer cell infusion every month in the absence of disease progression or unacceptable toxicity.
  • Other: Best Supportive Care
    Best Supportive Care in the absence of disease progression
  • Experimental: Immunotherapy
    Subjects receive autologous cytokine-induced killer cell infusion every month
    Intervention: Biological: Autologous cytokine-induced killer cell
  • Active Comparator: Best Supportive Care
    Best Supportive Care
    Intervention: Other: Best Supportive Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically proven small cell lung cancer
  • Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression
  • Age between 18-75
  • Performance status ≤2
  • No uncontrolled metabolic disease, infection, and neurological disorders
  • No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease
  • Life expectancy more than three months.
  • Without contraindication of immunotherapy with autologous cytokine-induced killer cells
  • No other malignancies
  • Signed study-specific consent form prior to study entry

Exclusion Criteria:

  • Patients receiving other anti-tumor therapy (like thermotherapy)
  • Pregnant or lactating women
  • Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells
  • Uncontrolled mental disorder
  • Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
Both
18 Years to 75 Years
No
Contact: Heming Lu, MD +86-771-218-6503 luhming3632@163.com
China
 
NCT01592422
CIKSCLC-2012
Yes
Guosheng Feng, People's Hospital of Guangxi
People's Hospital of Guangxi
Not Provided
Study Chair: Guosheng Feng, MD People's Hospital of Guangxi
Study Chair: Yuan Liang, MD Guangxi Department of Public Health
Study Chair: Hui Lin, MD, Phd People's Hospital of Guangxi
Study Chair: Heming Lu, MD People's Hospital of Guangxi
People's Hospital of Guangxi
July 2012

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