Back to resultsDC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
adenovirus-transfected DC + CIK
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Age >18 years at time of consent
- Histopathologically confirmed diagnosis of renal cell carcinoma
- Received standardized treatment of renal cell carcinoma
- Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
- KPS (Karnofsky performance scale) >60
- Patient's written informed consent
- Predicted survival >3 months
- No severe viral or bacterial infections
Exclusion Criteria:
- Receiving chemotherapy, radiotherapy or other therapy
- Patients with other malignancies and infectious diseases
- Pregnant and breast-feeding patient
- Currently participating in another clinical trial
- Unfit for participating in this clinical trial in investigators' opinions
Sites / Locations
- Department of Hematopoietic Stem Cell Transplantation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adenovirus-transfected DC + CIK
Arm Description
adenovirus-transfected autologous DC vaccine plus CIK cells
Outcomes
Primary Outcome Measures
objective tumor response (CR+PR) as measured by RECIST criteria
Secondary Outcome Measures
number of participants with adverse events
Full Information
NCT ID
NCT01924156
First Posted
August 14, 2013
Last Updated
February 18, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01924156
Brief Title
DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
Official Title
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 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 Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine 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
Renal Cell Carcinoma
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
Arm Title
adenovirus-transfected DC + CIK
Arm Type
Experimental
Arm Description
adenovirus-transfected autologous DC vaccine plus CIK cells
Intervention Type
Biological
Intervention Name(s)
adenovirus-transfected DC + CIK
Intervention Description
adenovirus-transfected DC vaccine plus CIK cells
Primary Outcome Measure Information:
Title
objective tumor 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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years at time of consent
Histopathologically confirmed diagnosis of renal cell carcinoma
Received standardized treatment of renal cell carcinoma
Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
KPS (Karnofsky performance scale) >60
Patient's written informed consent
Predicted survival >3 months
No severe viral or bacterial infections
Exclusion Criteria:
Receiving chemotherapy, radiotherapy or other therapy
Patients with other malignancies and infectious diseases
Pregnant and breast-feeding patient
Currently participating in another clinical trial
Unfit for participating in this clinical trial in investigators' opinions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Chen, M.D., Ph.D.
Organizational Affiliation
Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematopoietic Stem Cell Transplantation
City
Beijing
ZIP/Postal Code
100071
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24720900
Citation
Wang D, Zhang B, Gao H, Ding G, Wu Q, Zhang J, Liao L, Chen H. Clinical research of genetically modified dendritic cells in combination with cytokine-induced killer cell treatment in advanced renal cancer. BMC Cancer. 2014 Apr 10;14:251. doi: 10.1186/1471-2407-14-251.
Results Reference
derived
Learn more about this trial
DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
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