DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
February 18, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China, 100071
- Department of Hematopoietic Stem Cell Transplantation
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: adenovirus-transfected DC + CIK
adenovirus-transfected autologous DC vaccine plus CIK cells
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adenovirus-transfected DC vaccine plus CIK cells
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
objective tumor response (CR+PR) as measured by RECIST criteria
Time Frame: 4 weeks after DC/CIK treatment
|
4 weeks after DC/CIK treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of participants with adverse events
Time Frame: 3 days within DC/CIK treatment
|
3 days within DC/CIK treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hu Chen, M.D., Ph.D., Affiliated Hospital to Academy of Military Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2013
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
August 14, 2013
First Submitted That Met QC Criteria
August 15, 2013
First Posted (Estimate)
August 16, 2013
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307-CTC-DC/CIK-RCC
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.