Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
Recruitment status was: Not yet recruiting
30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options.
Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting cells.
The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma|
- overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Objective tumor response, Time to recurrence, Progression-free, Cellular immunity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Renal cell carcinoma patients were treated with three intravenous infusions of DC activated CIK cells at 1-day intervals. Clinical examinations of these patients were performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240005
|Stem cell cencter of the affiliated hospital of medical colledge,qingdao university|
|Qingdao, Shandong, China, 266000|
|Study Chair:||Yongheng An||The affilited hospital of medical college,Qingdao university|