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

July 2, 2012 updated by: Guosheng Feng, People's Hospital of Guangxi

Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Two years
Two years
Toxicities
Time Frame: Two years
Two years
Quality-of-life
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

July 2, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIKLC-201004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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