Small Cell Lung Cancer
Conditions
Keywords
Small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell
Brief summary
The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not been confirmed. Many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a 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 randomized controlled study was conducted to compare CIK cells with best supportive care as maintenance therapy for SCLC.
Interventions
BIOLOGICALAutologous cytokine-induced killer cell
Subjects receive autologous cytokine-induced killer cell infusion every month in the absence of disease progression or unacceptable toxicity.
OTHERBest Supportive Care
Best Supportive Care in the absence of disease progression
Sponsors
People's Hospital of Guangxi Zhuang Autonomous Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven small cell lung cancer * Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression * Age between 18-75 * Performance status ≤2 * No uncontrolled metabolic disease, infection, and neurological disorders * No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease * Life expectancy more than three months. * Without contraindication of immunotherapy with autologous cytokine-induced killer cells * No other malignancies * Signed study-specific consent form prior to study entry
Exclusion criteria
* Patients receiving other anti-tumor therapy (like thermotherapy) * Pregnant or lactating women * Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells * Uncontrolled mental disorder * Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | One year |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Two years |
| Quality-of-life | 2 years |
Countries
China
Contacts
Primary ContactHeming Lu, MD
Outcome results
None listed