Administration of Autologous Dendritic Cells (DCs) Infected With an Adenovirus Expressing Her-2

Following written, informed consent, consecutive cohorts of 3-6 patients, up to a maximum of 18 patients, will be treated at increasing dose levels based on a modified Fibonacci scheme. Peripheral blood progenitor cells will be obtained from each patient following cytokine mobilization (with GM-CSF and G-CSF). Selected CD34+ cells are then cultured with human GM-CSF, human TNFα, Flt-3 ligand and human interleukin-4. The CD34+ derived dendritic cells are then transduced with an adenovirus expressing rat HER2/neu. These transduced DCs are then injected intradermally into the patient. Patients will be injected with the AdHER2/neu transduced DCs every 21 days for a total of three treatment cycles. The starting dose of dendritic cells will be 10 X 10\^6 DCs. If none of the initial three patients treated at this dose experiences dose limiting toxicity (DLT) then a new cohort of three patients will be treated at a second dose level of 50 X 10\^6 DCs. If any patient experiences DLT then up to six patients will be treated at the current dose level; if 2/6 or fewer patients experience DLT, we will escalate to the to the second dose level. If 3 or more patients experience DLT, the maximum tolerated dose will be deemed as exceeded and a second cohort of 3 patients will be treated at a 10 fold dose reduction of the initial dose level. The third dose level will consist of 100 x 10\^6 DCs. All treatments will occur in the out-patient setting and patients will be seen prior to each injection and then monthly for at least three months following the last injection of AdHER2/neu DCs.