Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
This study is currently recruiting participants.
Verified July 2012 by People's Hospital of Guangxi
Sponsor:
People's Hospital of Guangxi
Information provided by (Responsible Party):
Guosheng Feng, People's Hospital of Guangxi
ClinicalTrials.gov Identifier:
NCT01592422
First received: April 26, 2012
Last updated: July 2, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Biological: Autologous cytokine-induced killer cell Other: Best Supportive Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by People's Hospital of Guangxi:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Quality-of-life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immunotherapy
Subjects receive autologous cytokine-induced killer cell infusion every month
|
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.
|
|
Active Comparator: Best Supportive Care
Best Supportive Care
|
Other: Best Supportive Care
Best Supportive Care in the absence of disease progression
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592422
Contacts
| Contact: Heming Lu, MD | +86-771-218-6503 | luhming3632@163.com |
Locations
| China, Guangxi | |
| The people's Hospital of the Guangxi Zhuang Autonomous Region | Recruiting |
| Nanning, Guangxi, China, 530021 | |
| Contact: Guosheng Feng, MD +86-771-218-6508 fengguosheng88988@163.com | |
Sponsors and Collaborators
People's Hospital of Guangxi
Investigators
| Study Chair: | Guosheng Feng, MD | People's Hospital of Guangxi |
| Study Chair: | Yuan Liang, MD | Guangxi Department of Public Health |
| Study Chair: | Hui Lin, MD, Phd | People's Hospital of Guangxi |
| Study Chair: | Heming Lu, MD | People's Hospital of Guangxi |
More Information
No publications provided
| Responsible Party: | Guosheng Feng, Professor, People's Hospital of Guangxi |
| ClinicalTrials.gov Identifier: | NCT01592422 History of Changes |
| Other Study ID Numbers: | CIKSCLC-2012 |
| Study First Received: | April 26, 2012 |
| Last Updated: | July 2, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by People's Hospital of Guangxi:
|
Small cell lung cancer Maintenance therapy Immunotherapy Autologous cytokine-induced killer cell |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013