Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Third Military Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gong Liang, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01498055
First received: November 24, 2011
Last updated: March 21, 2012
Last verified: December 2011
  Purpose

To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.


Condition Phase
Lung Cancer
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Disease Control Rates (DCR) [ Time Frame: From 12-2011 to 12-2013 ] [ Designated as safety issue: Yes ]
    Lung lesions of disease control rates DCR (CR + PR + SD), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST) standard


Secondary Outcome Measures:
  • Overall Survival(OS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Disease progression-free surial (Progression-Free Srvival, PFS) with observations


Biospecimen Retention:   Samples With DNA

The one-time folic acid sodium anticoagulation vacuum picks bag, through the venous blood sampling 60 ml. When blood alcohol on parts of the need blood disinfects processing. After the department shows will seal in a sterile bag, 16-21 degrees Celsius save, and transported to a cell biological treatment as soon as possible a follow-up operation center GMP laboratory.


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
CIK therapy group
control group

Detailed Description:

A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma, lung squamous cell carcinoma and large cell carcinoma) patients

Criteria

Inclusion Criteria:

  • 18~70 year old, KPS score >50 points, estimate survival > 3 months;
  • Primary lung cancer patients after chemotherapy or radiation therapy;
  • Primary lung cancer patients after targeted therapy;
  • Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
  • Primary lung cancer recurrence or surgery can't complete resection;
  • Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.);
  • No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases;
  • Patients Voluntary attempt, and informed consent.

Exclusion Criteria:

  • History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
  • Cachexia; or other deadly diseases;
  • Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
  • Active infection;
  • Pregnant or lactating women
  • At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
  • Now or recently will join another experimental clinical study ;
  • Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498055

Locations
China, Chong Qing
Liang Gong Recruiting
Chong Qing, Chong Qing, China, 400038
Contact: Liang Gong    13983965893    gonglw1@gmail.com   
Sub-Investigator: Liang Gong         
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Chair: Xiangdong Zhou Southwest Hospital Third Military University
  More Information

No publications provided

Responsible Party: Gong Liang, MD, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01498055     History of Changes
Other Study ID Numbers: GLiang
Study First Received: November 24, 2011
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board
China: Ministry of Health

Keywords provided by Third Military Medical University:
lung cancer
CIK cells
therapy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014