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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Group A:cytokine-induced killer cell +gefitinib

Group B:Gefitinib

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, CIK, Gefitinib, Adenocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Gefitinib combination with CIK cell immunotherapy

Gefitinib alone

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival

Full Information

NCT ID

NCT01871480

First Posted

June 4, 2013

Last Updated

December 26, 2013

Sponsor

Kunming Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01871480

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Terminated

Study Start Date

May 2013 (undefined)

Primary Completion Date

November 2015 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kunming Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

NSCLC, CIK, Gefitinib, Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Gefitinib combination with CIK cell immunotherapy

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Gefitinib alone

Intervention Type

Drug

Intervention Name(s)

Group A:cytokine-induced killer cell +gefitinib

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Group B:Gefitinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

up to 3 years

Other Pre-specified Outcome Measures:

Title

Quality-of-life

Time Frame

Three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xin Song, MD

Organizational Affiliation

The Third Affiliated Hospital of Kunming Medicine University

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650118

Country

China

12. IPD Sharing Statement

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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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