To hear about similar clinical trials, please enter your email below
Trial Title:
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer
NCT ID:
NCT01481259
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pemetrexed
Conditions: Keywords:
Nonsquamous non-small cell lung cancer
Maintenance therapy
Immunotherapy
Autologous cytokine-induced killer cell
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous cytokine-induced killer cell
Description:
Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the
absence of disease progression or unacceptable toxicity.
Arm group label:
Immunotherapy
Intervention type:
Other
Intervention name:
Pemetrexed
Description:
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence
of disease progression or unacceptable toxicity.
Arm group label:
Pemetrexed
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Start date:
January 2010
Completion date:
July 2013
Lead sponsor:
Agency:
People's Hospital of Guangxi
Agency class:
Other
Source:
People's Hospital of Guangxi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01481259
