DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 22, 2016
February 1, 2016
3.4 years
August 14, 2013
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
objective tumor response (CR+PR) as measured by RECIST criteria
4 weeks after DC/CIK treatment
Secondary Outcomes (1)
number of participants with adverse events
3 days within DC/CIK treatment
Study Arms (1)
adenovirus-transfected DC + CIK
EXPERIMENTALadenovirus-transfected autologous DC vaccine plus CIK cells
Interventions
adenovirus-transfected DC vaccine plus CIK cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hematopoietic Stem Cell Transplantation
Beijing, 100071, China
Related Publications (1)
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.
PMID: 24720900DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hu Chen, M.D., Ph.D.
Affiliated Hospital to Academy of Military Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 16, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 22, 2016
Record last verified: 2016-02