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CIK Cell Transfusion Plus Gefitinib As Second Or Third-Line Treatment for Advanced Adenocarcinoma Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01871480
Recruitment Status : Terminated
First Posted : June 6, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Song Xin, Kunming Medical University

Brief Summary:
Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. Gefitinib showed lower efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Immunotherapy with cytokine-induced killer cells (CIK) may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Group A:cytokine-induced killer cell +gefitinib Drug: Group B:Gefitinib Phase 2

Detailed Description:
Lung cancer is the most common cancer worldwide, non-small cell lung cancer (NSCLC) comprises about 85% of all lung cancer cases, which is the leading cause of cancer mortality, and adenocarcinoma is the most prevalent subtype. The epidermal growth factor receptor (EGFR) adenosine triphosphate-competitive tyrosine kinase inhibitors gefitinib showed success in the treatment of advanced adenocarcinoma NSCLC following the failure of front-line chemotherapy. However, the efficiency of treatment as second or third-line in patients with advanced adenocarcinoma NSCLC is also low. It is necessary to further improve the efficiency of treatment in patients with advanced NSCLC. Biological treatment is an effective adjuvant treatment in comprehensive cancer treatment. Immunotherapy with cytokine-induced killer cells (CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum, this effect may improve tumor control and survival, as well as a better quality of life. This study is to evaluate the efficacy of Autologous CIK Transfusion plus Gefitinib for advanced, recurrence, metastatic adenocarcinoma NSCLC.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Controlled Study of Gefitinib Plus Autologous Cytokine-Induced Killer Cell Immunotherapy(CIK)Versus Gefitinib Alone As Second Or Third-Line Treatment in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer
Study Start Date : May 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Group A
Gefitinib combination with CIK cell immunotherapy
Drug: Group A:cytokine-induced killer cell +gefitinib
CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.

Active Comparator: Group B
Gefitinib alone
Drug: Group B:Gefitinib
Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]

Other Outcome Measures:
  1. Quality-of-life [ Time Frame: Three years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 to 80 years
  • Histologically or cytologically proven advanced adenocarcinoma non-small-cell lung cancer
  • Life expectancy more than 12 weeks
  • Not received EGFR agent or cell immunotherapy before entry into this study
  • World Health Organization- Eastern Cooperative Oncology Group Performance Status 0-3
  • Gefitinib as the second or third line therapy
  • More than 4 weeks must have completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects
  • Disease measurable
  • Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.0×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 75×109/L, Hemoglobin more than 80g/L, Serum total bilirubin less than 1.25 folds of the upper normal limit (ULN), Serum glutamic-oxal (o) acetic transaminase: less than 2.5×ULN, Serum glutamate pyruvate transaminase: less than 2.5×ULN, Serum creatinine: less than 1.25×ULN, Blood urea nitrogen: less than 2×ULN.
  • Pregnancy test: the test of women of child-bearing period must be negative before entry into this study
  • Subject must have good compliance and voluntarily to sign a written informed consent

Exclusion Criteria:

  • Acute infection
  • Uncontrolled concurrent illness: hypersensitiveness, asthma, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, serious heart valve disease
  • Psychiatric illness, pharmacological dependence, or other situation that would limit compliance with study requirements
  • History of other neoplasms
  • Coagulation disorder and bleeding tendency
  • Pertinacious hypertension(systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) after aggressive therapy
  • Brain metastasis with symptomatic
  • Severe liver dysfunction
  • Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, thyroadenitis, et al )
  • Patients who diagnosed as virus hepatitis, syphilis or HIV, or other infectious diseases
  • Employment of corticosteroids or other immunodepressive hormone therapies
  • With main organs transplantation
  • Pregnant or lactating women
  • Known or suspected in patients with severe hypersensitivity to CIK or gefitinib or to any other component of gefitinib
  • Patients receiving any other investigational agents in 30 days or prepare to participate in other investigation in the clinical period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871480


Locations
China, Yunnan
Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University
Kunming, Yunnan, China, 650118
Sponsors and Collaborators
Kunming Medical University
Investigators
Study Chair: Xin Song, MD The Third Affiliated Hospital of Kunming Medicine University

Responsible Party: Song Xin, Chief of the Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University, Kunming Medical University
ClinicalTrials.gov Identifier: NCT01871480     History of Changes
Other Study ID Numbers: CIK plus gefitinib
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Song Xin, Kunming Medical University:
NSCLC
CIK
Gefitinib
Adenocarcinoma

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action