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
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Biological: Autologous cytokine-induced killer cell
Other: Best Supportive Care
Phase 2

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 Small Cell Lung Cancer

Resource links provided by NLM:


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 ]
  • Quality-of-life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immunotherapy
Subjects receive autologous cytokine-induced killer cell infusion every month
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.
Active Comparator: Best Supportive Care
Best Supportive Care
Other: Best Supportive Care
Best Supportive Care in the absence of disease progression

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592422

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

Locations
China, Guangxi
The people's Hospital of the Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530021
Contact: Guosheng Feng, MD    +86-771-218-6508    fengguosheng88988@163.com   
Sponsors and Collaborators
People's Hospital of Guangxi
Investigators
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
  More Information

No publications provided

Responsible Party: Guosheng Feng, Professor, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT01592422     History of Changes
Other Study ID Numbers: CIKSCLC-2012
Study First Received: April 26, 2012
Last Updated: July 2, 2012
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014