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

NCT01481259 | Unknown Phase 2 DMC

• 1 other identifier: CIKLC-201004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Nonsquamous non-small cell lung cancer; Maintenance therapy; Immunotherapy; Autologous cytokine-induced killer cell; Pemetrexed

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  One year

Secondary Outcomes (3)

• Overall survival

  Two years

• Toxicities

  Two years

• Quality-of-life

  Two years

Study Arms (2)

Immunotherapy

EXPERIMENTAL

Subjects receive autologous cytokine-induced killer cell infusion every 21 days

Biological: Autologous cytokine-induced killer cell

Pemetrexed

ACTIVE COMPARATOR

Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days

Other: Pemetrexed

Interventions

Autologous cytokine-induced killer cell BIOLOGICAL

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

Immunotherapy

Pemetrexed OTHER

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

Pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• People's Hospital of Guangxi Zhuang Autonomous Region: lead

Study Sites (1)

Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Guosheng Feng, M.D

  People's Hospital of Guangxi Zhuang Autonomous Region

  PRINCIPAL INVESTIGATOR

• Hui Lin, M.D

  People's Hospital of Guangxi Zhuang Autonomous Region

  STUDY CHAIR

• Yuan Liang, M.D

  Guangxi Department of Public Health

  STUDY CHAIR

• Heming Lu, M.D

  People's Hospital of Guangxi Zhuang Autonomous Region

  STUDY CHAIR

Central Study Contacts

Heming Lu, M.D

CONTACT

86-771-218-6503; luhming3632@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 29, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 3, 2012

Record last verified: 2012-07

Locations

CN (1)