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

NCT01592422 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-07-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Autologous cytokine-induced killer cell

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

OTHER

Best Supportive Care

Best Supportive Care in the absence of disease progression

Sponsors & Collaborators

  • People's Hospital of Guangxi Zhuang Autonomous Region

    lead OTHER

Principal Investigators

  • Guosheng Feng, MD · People's Hospital of Guangxi Zhuang Autonomous Region

  • Yuan Liang, MD · Guangxi Department of Public Health

  • Hui Lin, MD, Phd · People's Hospital of Guangxi Zhuang Autonomous Region

  • Heming Lu, MD · People's Hospital of Guangxi Zhuang Autonomous Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592422 on ClinicalTrials.gov