Primary Outcome Measures:
Secondary Outcome Measures:
- Clinical Response
Clinical Response will be determined by RECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
- Dose limiting toxicity
Dose-limiting toxicity is defined as: any Grade 3 or higher allergic, autoimmune or injection site reaction or any Grade 4 hematologic or non-hematologic toxicity (except fever).
- Immune Response Immune Response
Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLAA2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a 3 fold increase relative to pre-vaccination.
OCDC,an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab.