Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Stage IIIb/IV Nonsquamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01481259
• Other study ID #: CIKLC-201004
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 16, 2011
• Last updated: July 2, 2012
• Start date: January 2010
• Est. completion date: July 2013

Study information

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

Clinical Trial Summary

Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an 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 randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven nonsquamous non-small cell lung cancer

• Stage IIIb-IV, according to AJCC 2010 Staging System

• Disease measurable

• Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy

• No chemotherapy or radiotherapy prior to first-line therapy

• Age between 18-75

• Performance status <2

• No congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease

• No uncontrolled metabolic disease, infection, and neurological disorders

• No other malignancies

• Signed study-specific consent form prior to study entry

Exclusion Criteria:

• Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy

• Pregnant or lactating women

• Patient having hepatitis B virus infection, active tuberculosis, or other 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

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Biological:
• Autologous cytokine-induced killer cell
Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.

Other:
• Pemetrexed
Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
China	Clinical Cancer Center, People's Hospital of 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	Toxicities		Two years	Yes
Secondary	Quality-of-life		Two years	Yes