- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592422
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
July 2, 2012 updated by: Guosheng Feng, People's Hospital of Guangxi
Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heming Lu, MD
- Phone Number: +86-771-218-6503
- Email: luhming3632@163.com
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Recruiting
- The people's Hospital of the Guangxi Zhuang Autonomous Region
-
Contact:
- Guosheng Feng, MD
- Phone Number: +86-771-218-6508
- Email: fengguosheng88988@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immunotherapy
Subjects receive autologous cytokine-induced killer cell infusion every month
|
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 in the absence of disease progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Two years
|
Two years
|
Quality-of-life
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yuan Liang, MD, Guangxi Department of Public Health
- Study Chair: Guosheng Feng, MD, People's Hospital of Guangxi
- Study Chair: Hui Lin, MD, Phd, People's Hospital of Guangxi
- Study Chair: Heming Lu, MD, People's Hospital of Guangxi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
April 26, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
July 3, 2012
Last Update Submitted That Met QC Criteria
July 2, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIKSCLC-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Cell Lung Cancer
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
Washington University School of MedicineMerck Sharp & Dohme LLCWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Small Cell Lung Extensive Stage
-
Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
Clinical Trials on Autologous cytokine-induced killer cell
-
Alliancells-PuRui Biocience Co., Ltd.Zhongyuan Union Stem Cell Bio-engineering CorporationUnknownRenal Cell Carcinoma | Hepatocellular Carcinoma | Lung CancerChina
-
Siriraj HospitalMahidol UniversityUnknownCholangiocarcinomaThailand
-
Robert NegrinNational Institutes of Health (NIH)UnknownMultiple Myeloma | Blood and Marrow Transplant (BMT)United States
-
The First People's Hospital of ChangzhouActive, not recruitingUrinary Bladder Neoplasms
-
The First People's Hospital of ChangzhouNot yet recruitingEsophageal Squamous Cell Carcinoma
-
Sun Yat-sen UniversityCompletedHepatocellular CarcinomaChina
-
Yanjuan ZhuUnknown
-
Henan Cancer HospitalHenan Provincial People's Hospital; Hebei Medical University Fourth Hospital; Tangshan People's Hospital and other collaboratorsTerminated
-
The First People's Hospital of ChangzhouActive, not recruiting
-
The First People's Hospital of ChangzhouActive, not recruiting