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

NCT01871480 | Terminated Phase 2 DMC

• 1 other identifier: CIK plus gefitinib
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; CIK; Gefitinib; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  up to 2 years

Secondary Outcomes (1)

• Overall survival

  up to 3 years

Other Outcomes (1)

• Quality-of-life

  Three years

Study Arms (2)

Group A

EXPERIMENTAL

Gefitinib combination with CIK cell immunotherapy

Drug: Group A:cytokine-induced killer cell +gefitinib

Group B

ACTIVE COMPARATOR

Gefitinib alone

Drug: Group B:Gefitinib

Interventions

Group A:cytokine-induced killer cell +gefitinib DRUG

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.

Group A

Group B:Gefitinib DRUG

Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kunming Medical University: lead

Study Sites (1)

Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Xin Song, MD

  The Third Affiliated Hospital of Kunming Medicine University

  STUDY CHAIR

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: Chief of the Department of Cancer Biotherapy Center, The Third Affiliated Hospital of Kunming Medicine University

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2016
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

CN (1)