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

Phase 2

• Conditions: Small Cell Lung Cancer
• Interventions: Biological: Autologous cytokine-induced killer cell; Other: Best Supportive Care

• Registration Number: NCT01592422
• Lead Sponsor: People's Hospital of Guangxi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Status Verified: 2012-07
• Study Start: 2012-07
• Last Update Submitted: 2012-07-02
• Last Update Posted: 2012-07-03
• Primary Completion: 2015-07
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunotherapy	Autologous cytokine-induced killer cell	Subjects receive autologous cytokine-induced killer cell infusion every month
Best Supportive Care	Best Supportive Care	Best Supportive Care

Primary Outcome Measures

Name	Time	Method
Progression-free survival	One year

Secondary Outcome Measures

Name	Time	Method
Overall survival	Two years
Quality-of-life	2 years

Trial Locations

Locations (1)

The people's Hospital of the Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China