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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01592422
• Other study ID #: CIKSCLC-2012
• Status: Recruiting
• Phase: Phase 2
• First received: April 26, 2012
• Last updated: July 2, 2012
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: July 2012
• Source: People's Hospital of Guangxi
• Contact: Heming Lu, MD
• Phone: +86-771-218-6503
• Email: luhming3632[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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.

Other:
• Best Supportive Care
Best Supportive Care in the absence of disease progression

Locations

Country	Name	City	State
China	The people's Hospital of the Guangxi Zhuang Autonomous Region	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
People's Hospital of Guangxi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		One year	No
Secondary	Overall survival		Two years	No
Secondary	Quality-of-life		2 years	Yes