NCT01592422

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 3, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

April 26, 2012

Last Update Submit

July 2, 2012

Conditions

Small Cell Lung Cancer

Keywords

Small cell lung cancerMaintenance therapyImmunotherapyAutologous cytokine-induced killer cell

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    One year

Secondary Outcomes (2)

  • Overall survival

    Two years

  • Quality-of-life

    2 years

Study Arms (2)

Immunotherapy

EXPERIMENTAL

Subjects receive autologous cytokine-induced killer cell infusion every month

Biological: Autologous cytokine-induced killer cell

Best Supportive Care

ACTIVE COMPARATOR

Best Supportive Care

Other: Best Supportive Care

Interventions

Autologous cytokine-induced killer cellBIOLOGICAL

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

Immunotherapy
Best Supportive CareOTHER

Best Supportive Care in the absence of disease progression

Best Supportive Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The people's Hospital of the Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Guosheng Feng, MD

    People's Hospital of Guangxi Zhuang Autonomous Region

    STUDY CHAIR

  • Yuan Liang, MD

    Guangxi Department of Public Health

    STUDY CHAIR

  • Hui Lin, MD, Phd

    People's Hospital of Guangxi Zhuang Autonomous Region

    STUDY CHAIR

  • Heming Lu, MD

    People's Hospital of Guangxi Zhuang Autonomous Region

    STUDY CHAIR

Central Study Contacts

Heming Lu, MD

CONTACT

+86-771-218-6503luhming3632@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2012

First Posted

May 7, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

July 3, 2012

Record last verified: 2012-07

Locations

CN(1)