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

People's Hospital of Guangxi

Status and phase: Unknown; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Biological: Autologous cytokine-induced killer cell; Other: Best Supportive Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01592422

CIKSCLC-2012

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immunotherapy

Experimental group

Description:

Subjects receive autologous cytokine-induced killer cell infusion every month

Treatment:

Biological: Autologous cytokine-induced killer cell

Best Supportive Care

Active Comparator group

Description:

Best Supportive Care

Treatment:

Other: Best Supportive Care