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Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Autologous cytokine-induced killer cell

Best Supportive Care

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically proven small cell lung cancer
Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression
Age between 18-75
Performance status ≤2
No uncontrolled metabolic disease, infection, and neurological disorders
No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease
Life expectancy more than three months.
Without contraindication of immunotherapy with autologous cytokine-induced killer cells
No other malignancies
Signed study-specific consent form prior to study entry

Exclusion Criteria:

Patients receiving other anti-tumor therapy (like thermotherapy)
Pregnant or lactating women
Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells
Uncontrolled mental disorder
Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases

Sites / Locations

The people's Hospital of the Guangxi Zhuang Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunotherapy

Best Supportive Care

Arm Description

Subjects receive autologous cytokine-induced killer cell infusion every month

Best Supportive Care

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival

Quality-of-life

Full Information

NCT ID

NCT01592422

First Posted

April 26, 2012

Last Updated

July 2, 2012

Sponsor

People's Hospital of Guangxi

1. Study Identification

Unique Protocol Identification Number

NCT01592422

Brief Title

Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

Official Title

Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

People's Hospital of Guangxi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not been confirmed. Many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a 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 randomized controlled study was conducted to compare CIK cells with best supportive care as maintenance therapy for SCLC.

6. Conditions and Keywords

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

Small Cell Lung Cancer

Keywords

Small cell lung cancer, Maintenance therapy, Immunotherapy, Autologous cytokine-induced killer cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunotherapy

Arm Type

Experimental

Arm Description

Subjects receive autologous cytokine-induced killer cell infusion every month

Arm Title

Best Supportive Care

Arm Type

Active Comparator

Arm Description

Best Supportive Care

Intervention Type

Biological

Intervention Name(s)

Autologous cytokine-induced killer cell

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Best Supportive Care

Intervention Description

Best Supportive Care in the absence of disease progression

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

One year

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

Two years

Title

Quality-of-life

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically proven small cell lung cancer Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression Age between 18-75 Performance status ≤2 No uncontrolled metabolic disease, infection, and neurological disorders No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease Life expectancy more than three months. Without contraindication of immunotherapy with autologous cytokine-induced killer cells No other malignancies Signed study-specific consent form prior to study entry Exclusion Criteria: Patients receiving other anti-tumor therapy (like thermotherapy) Pregnant or lactating women Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells Uncontrolled mental disorder Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heming Lu, MD

Phone

+86-771-218-6503

luhming3632@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guosheng Feng, MD

Organizational Affiliation

People's Hospital of Guangxi

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yuan Liang, MD

Organizational Affiliation

Guangxi Department of Public Health

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hui Lin, MD, Phd

Organizational Affiliation

People's Hospital of Guangxi

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Heming Lu, MD

Organizational Affiliation

People's Hospital of Guangxi

Official's Role

Study Chair

Facility Information:

Facility Name

The people's Hospital of the Guangxi Zhuang Autonomous Region

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guosheng Feng, MD

Phone

+86-771-218-6508

fengguosheng88988@163.com

12. IPD Sharing Statement

Learn more about this trial

Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

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