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Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Nonsquamous Non-small Cell Lung Cancer

NCT ID: NCT01481259

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/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-07-31

Brief Summary

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Maintenance therapy has been considered as an important component to prolong survival in patients with advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC). Previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage IIIb-IV nonsquamous non-small cell lung cancer. With the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an 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 randomised controlled study was conducted to compare CIK cells with pemetrexed as maintenance therapy for stage IIIb-IV nonsquamous non-small cell lung cancer.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Keywords

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Nonsquamous non-small cell lung cancer Maintenance therapy Immunotherapy Autologous cytokine-induced killer cell Pemetrexed

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 21 days

Group Type EXPERIMENTAL

Autologous cytokine-induced killer cell

Intervention Type BIOLOGICAL

Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.

Pemetrexed

Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type OTHER

Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions

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Autologous cytokine-induced killer cell

Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.

Intervention Type BIOLOGICAL

Pemetrexed

Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven nonsquamous non-small cell lung cancer
* Stage IIIb-IV, according to AJCC 2010 Staging System
* Disease measurable
* Patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy
* No chemotherapy or radiotherapy prior to first-line therapy
* Age between 18-75
* Performance status \<2
* No congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease
* No uncontrolled metabolic disease, infection, and neurological disorders
* No other malignancies
* Signed study-specific consent form prior to study entry

Exclusion Criteria

* Patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy
* Pregnant or lactating women
* Patient having hepatitis B virus infection, active tuberculosis, or other 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, M.D

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Guangxi Zhuang Autonomous Region

Hui Lin, M.D

Role: STUDY_CHAIR

People's Hospital of Guangxi Zhuang Autonomous Region

Yuan Liang, M.D

Role: STUDY_CHAIR

Guangxi Department of Public Health

Heming Lu, M.D

Role: STUDY_CHAIR

People's Hospital of Guangxi Zhuang Autonomous Region

Locations

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Clinical Cancer Center, People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Heming Lu, M.D

Role: CONTACT

Phone: 86-771-218-6503

Email: [email protected]

Other Identifiers

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CIKLC-201004

Identifier Type: -

Identifier Source: org_study_id