PRIMARY OBJECTIVES:
I. To evaluate the feasibility of expanding HER-2-specific effector T cells (TE) ex vivo from CD62L+ TCM and CD62L- TEM from patients immunized with a HER-2 peptide vaccine.
II. To evaluate the safety of infusing autologous ex vivo expanded HER-2-specific T cells into patients with advanced HER-2+ breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the persistence, function, and phenotype of adoptively transferred HER-2-specific TE cells derived from TCM or TEM precursors.
II. To investigate the potential anti-tumor effects of therapy with ex vivo expanded HER-2-specific T cells in patients with advanced HER-2+ breast cancer.
OUTLINE : This is a dose-escalation study of ex vivo-expanded HER2-specific T cells.
VACCINE THERAPY: Patients receive HER2 peptide vaccine intradermally once weekly for 3 weeks.
CHEMOTHERAPY: Patients receive cyclophosphamide IV on day -1.
IMMUNOTHERAPY: Patients receive ex vivo-expanded HER2 specific T-cell IV over 30 minutes on days 1, 10, and 20.
After completion of study treatment, patients are followed up on days 28, 35, 49, 63 and then monthly thereafter for 1 year.