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

NCT ID: NCT01592422

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Small Cell Lung Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunotherapy

Subjects receive autologous cytokine-induced killer cell infusion every month

Group Type EXPERIMENTAL

Autologous cytokine-induced killer cell

Intervention Type BIOLOGICAL

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

Best Supportive Care

Best Supportive Care

Group Type ACTIVE_COMPARATOR

Best Supportive Care

Intervention Type OTHER

Best Supportive Care in the absence of disease progression

Interventions

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Autologous cytokine-induced killer cell

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

Intervention Type BIOLOGICAL

Best Supportive Care

Best Supportive Care in the absence of disease progression

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role lead

Responsible Party

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Guosheng Feng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guosheng Feng, MD

Role: STUDY_CHAIR

People's Hospital of Guangxi Zhuang Autonomous Region

Yuan Liang, MD

Role: STUDY_CHAIR

Guangxi Department of Public Health

Hui Lin, MD, Phd

Role: STUDY_CHAIR

People's Hospital of Guangxi Zhuang Autonomous Region

Heming Lu, MD

Role: STUDY_CHAIR

People's Hospital of Guangxi Zhuang Autonomous Region

Locations

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The people's Hospital of the Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Heming Lu, MD

Role: CONTACT

Phone: +86-771-218-6503

Email: [email protected]

Facility Contacts

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Guosheng Feng, MD

Role: primary

Other Identifiers

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CIKSCLC-2012

Identifier Type: -

Identifier Source: org_study_id