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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Autologous cytokine-induced killer cell
Pemetrexed
Sponsored by
People's Hospital of Guangxi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Nonsquamous non-small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell, Pemetrexed

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunotherapy

Pemetrexed

Arm Description

Subjects receive autologous cytokine-induced killer cell infusion every 21 days

Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Toxicities
Quality-of-life

Full Information

First Posted
November 16, 2011
Last Updated
July 2, 2012
Sponsor
People's Hospital of Guangxi
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1. Study Identification

Unique Protocol Identification Number
NCT01481259
Brief Title
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
Official Title
Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
People's Hospital of Guangxi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Nonsquamous non-small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell, Pemetrexed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunotherapy
Arm Type
Experimental
Arm Description
Subjects receive autologous cytokine-induced killer cell infusion every 21 days
Arm Title
Pemetrexed
Arm Type
Active Comparator
Arm Description
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days
Intervention Type
Biological
Intervention Name(s)
Autologous cytokine-induced killer cell
Intervention Description
Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
Pemetrexed
Intervention Description
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
One year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Two years
Title
Toxicities
Time Frame
Two years
Title
Quality-of-life
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heming Lu, M.D
Phone
86-771-218-6503
Email
luhming3632@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guosheng Feng, M.D
Organizational Affiliation
People's Hospital of Guangxi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Lin, M.D
Organizational Affiliation
People's Hospital of Guangxi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuan Liang, M.D
Organizational Affiliation
Guangxi Department of Public Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heming Lu, M.D
Organizational Affiliation
People's Hospital of Guangxi
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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