Back to resultsDC Vaccine Combined With CIK Cells in Patients With SCLC
Primary Purpose
Small- Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
adenovirus-transfected autologous DC vaccine plus CIK cells
Sponsored by
About this trial
This is an interventional treatment trial for Small- Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histopathologically confirmed diagnosis of Small- Cell Lung Cancer
- Age >18 years at time of consent
- Received standardized treatment of Small-Cell Lung Cancer
- Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- KPS (Karnofsky performance scale) >60
- Patient's written informed consent
- No severe viral or bacterial infections
- Predicted survival >3 months
Exclusion Criteria:
- Clinically relevant diseases or infections (HBV, HCV, HIV)
- Females who are pregnant or nursing
- Immunosuppressant treatment
- Currently participating in another clinical trial
- Unfit for participating in this clinical trial in investigators' opinions
Sites / Locations
Outcomes
Primary Outcome Measures
objective rate response (CR+PR) as measured by RECIST criteria
Secondary Outcome Measures
number of participants with adverse events
Full Information
NCT ID
NCT02688673
First Posted
February 18, 2016
Last Updated
February 18, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02688673
Brief Title
DC Vaccine Combined With CIK Cells in Patients With SCLC
Official Title
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC combined with CIK cells, the investigators plan to perform the clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small- Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
adenovirus-transfected autologous DC vaccine plus CIK cells
Primary Outcome Measure Information:
Title
objective rate response (CR+PR) as measured by RECIST criteria
Time Frame
4 weeks after DC/CIK treatment]
Secondary Outcome Measure Information:
Title
number of participants with adverse events
Time Frame
3 days within DC/CIK treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically confirmed diagnosis of Small- Cell Lung Cancer
Age >18 years at time of consent
Received standardized treatment of Small-Cell Lung Cancer
Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
KPS (Karnofsky performance scale) >60
Patient's written informed consent
No severe viral or bacterial infections
Predicted survival >3 months
Exclusion Criteria:
Clinically relevant diseases or infections (HBV, HCV, HIV)
Females who are pregnant or nursing
Immunosuppressant treatment
Currently participating in another clinical trial
Unfit for participating in this clinical trial in investigators' opinions
12. IPD Sharing Statement
Learn more about this trial
DC Vaccine Combined With CIK Cells in Patients With SCLC
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