DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating Patients With Renal Cell Carcinoma
Recruitment status was: Recruiting
Renal Cell Carcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Autologous Dendritic Cells (DC) Loaded With Autologous Tumor Lysate (DC-Vaccine) in Combination With Cytokine-Induced Killer Cell (CIK) in Patients With Renal Cell Cancer|
- Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria. [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
- Immunity as measured by T-cell functionality (immuknow assay )to the tumor. Safety as measured by NCI common toxicity table （CTC） at completion of study. [ Time Frame: at screening, baseline, weeks 4 , 12 and years 1 after first vaccination, and at completion of study treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Placebo Comparator: IL-2/IFN-α||
Patients receive treatment of IL-2 or IFN-α.
Other Name: 2
Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.
Other Name: 1
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.
1. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).
- Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
- Determine safety of multiple administrations of this regimens in these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862303
|Fuzhou General Hospital|
|Fuzhou, Fujian, China, 350025|
|Principal Investigator:||Jianming Tan, M.D.||Fuzhou General Hospital|