Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Biological: Autologous cytokine-induced killer cell
* Other: Best Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunotherapy<br>Subjects receive autologous cytokine-induced killer cell infusion every month | Biological: Autologous cytokine-induced killer cell<br>* Subjects receive autologous cytokine-induced killer cell infusion every month in the absence of disease progression or unacceptable toxicity.<br>|
| Active Comparator: Best Supportive Care<br>Best Supportive Care | Other: Best Supportive Care<br>* Best Supportive Care in the absence of disease progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Two years | 
| Quality-of-life |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell