A Phase II Study of VEGF Blockade With Bevacizumab Combined With Autologous Tumor/Dendritic Cell Vaccine (DC Vaccine), Interleukin-2 (IL-2) and Interferon-α-2b (IFNα-2b) in Patients With Metastatic Renal Cell Carcinoma (RCC)
All eligible patients will receive a total of five treatment weeks, each consisting of
approximately 5 days. Prior to therapy, patients will undergo apheresis for DC preparation.
DC-Tumor vaccines will be frozen in 90% pooled human AB serum/ 10% DMSO to be used for
treatment Patients will be dosed with bevacizumab (10mg/kg, Genentech) intravenously every
two weeks beginning four weeks prior to the first vaccine. Each treatment week includes
ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of
continuous intravenous infusion of IL-2 (18 MiU/m2, Novartis), and three subcutaneous
injections of IFNa-2b (6 MiU, Schering -Plough Corp.) (every other day). The first two
treatment weeks, the induction phase, will be separated by a 9 day rest. Three additional
treatment weeks, the maintenance phase, will be separated by 23 rest days.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective clinical response rate and progression free survival (PFS) to this combined treatment regimen.
Marc S Ernstoff, MD
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|