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

Sponsor

People's Hospital of Guangxi (Other)

Overall Status

Unknown status

CT.gov ID

NCT01592422

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Biological: Autologous cytokine-induced killer cell Other: Best Supportive Care	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Immunotherapy

Subjects receive autologous cytokine-induced killer cell infusion every month

Biological: Autologous cytokine-induced killer cell

Subjects receive autologous cytokine-induced killer cell infusion every month in the absence of disease progression or unacceptable toxicity.

Active Comparator: Best Supportive Care

Best Supportive Care

Other: Best Supportive Care

Best Supportive Care in the absence of disease progression

Outcome Measures

Primary Outcome Measures

Progression-free survival [One year]

Secondary Outcome Measures

Overall survival [Two years]
Quality-of-life [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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