Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
Conditions
Small Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
Small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Autologous cytokine-induced killer cell Type: Biological
Name: Best Supportive Care Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
The people's Hospital of the Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Status: Recruiting
Contact: Guosheng Feng, MD - +86-771-218-6508 - fengguosheng88988@163.com
Start Date
July 2012
Completion Date
September 2015
Sponsors
People's Hospital of Guangxi
Source
People's Hospital of Guangxi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page