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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. 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
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: adenovirus-transfected DC + CIK Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: adenovirus-transfected DC + CIK
adenovirus-transfected autologous DC vaccine plus CIK cells
Biological: adenovirus-transfected DC + CIK
adenovirus-transfected DC vaccine plus CIK cells

Primary Outcome Measures :
  1. objective tumor response (CR+PR) as measured by RECIST criteria [ Time Frame: 4 weeks after DC/CIK treatment ]

Secondary Outcome Measures :
  1. number of participants with adverse events [ Time Frame: 3 days within DC/CIK treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01924156

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Department of Hematopoietic Stem Cell Transplantation
Beijing, China, 100071
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
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Principal Investigator: Hu Chen, M.D., Ph.D. Affiliated Hospital to Academy of Military Medical Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences Identifier: NCT01924156    
Other Study ID Numbers: 307-CTC-DC/CIK-RCC
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs