One Dose of Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine

PRIMARY OBJECTIVES: I. To assess the feasibility of expanding HER2 specific T cells ex vivo
for infusion into subjects who have advanced HER2 overexpressing cancer. II. To assess the
toxicity associated with infusing autologous HER2 specific T cells into patients using
either a single dose of cyclophosphamide or ONTAK (denileukin diftitox) prior to T cell
infusion. SECONDARY OBJECTIVES: I. To investigate to what extent HER2 specific T cell
immunity can be boosted in individuals treated with a single dose of cyclophosphamide of
ONTAK (denileukin diftitox) followed by infusion of autologous HER2 specific T cells. II. To
investigate the potential anti-tumor effects of HER2 specific T cells in patients with HER2
overexpressing advanced-stage cancers. III. To evaluate how long tumor antigen specific T
cell immune augmentation persists in vivo after a single dose of cyclophosphamide or ONTAK
(denileukin diftitox) followed by infusion of autologous HER2 specific T cells. OUTLINE:
This is a dose-escalation study of ex vivo-expanded HER2-specific T cells. Patients are
assigned to 1 of 2 treatment groups. GROUP A: Patients receive low-dose cyclophosphamide IV
on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV
over 30 minutes on days 1, 10, and 20. GROUP B: Patients receive denileukin diftitox IV over
1 hour on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells
IV over 30 minutes on days 1, 10, and 20. After completion of study treatment, patients are
followed periodically.