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Trial record 91 of 534 for:    stem cell kidney

DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924156
Recruitment Status : Unknown
Verified February 2016 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 16, 2013
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 14, 2013
First Posted Date  ICMJE August 16, 2013
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
objective tumor response (CR+PR) as measured by RECIST criteria [ Time Frame: 4 weeks after DC/CIK treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01924156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
number of participants with adverse events [ Time Frame: 3 days within DC/CIK treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
Official Title  ICMJE Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Biological: adenovirus-transfected DC + CIK
adenovirus-transfected DC vaccine plus CIK cells
Study Arms  ICMJE Experimental: adenovirus-transfected DC + CIK
adenovirus-transfected autologous DC vaccine plus CIK cells
Intervention: Biological: adenovirus-transfected DC + CIK
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01924156
Other Study ID Numbers  ICMJE 307-CTC-DC/CIK-RCC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiliated Hospital to Academy of Military Medical Sciences
Study Sponsor  ICMJE Affiliated Hospital to Academy of Military Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hu Chen, M.D., Ph.D. Affiliated Hospital to Academy of Military Medical Sciences
PRS Account Affiliated Hospital to Academy of Military Medical Sciences
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP