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

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

History of Changes

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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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 (Adult, Senior)
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

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: 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


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 September 28, 2016

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