Clinical trial NCT01592422: Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
Official title: Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Small cell lung cancer
Maintenance therapy
Immunotherapy
Autologous cytokine-induced killer cell
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: Two years
measure: Quality-of-life
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanning
country: China
facility: The people's Hospital of the Guangxi Zhuang Autonomous Region
state: Guangxi
Study officials:
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Guosheng Feng, MD
role: STUDY_CHAIR
affiliation: Guangxi Department of Public Health
name: Yuan Liang, MD
role: STUDY_CHAIR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Hui Lin, MD, Phd
role: STUDY_CHAIR
affiliation: People's Hospital of Guangxi Zhuang Autonomous Region
name: Heming Lu, MD
role: STUDY_CHAIR
References: