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
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).
1. Determine cellular immune response response in terms of immuknow assay, and correlate
immune response with objective clinical response in patients treated with this regimen.
2. Determine safety of multiple administrations of this regimens in these patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response (complete and partial response), Time to recurrence (TTR), Progression-free(PFS) and overall survival(OS) as measured by RECIST criteria.
every 3 months
Jianming Tan, M.D.
Fuzhou General Hospital
China: Ministry of Health