Purpose and Rationale: This proposal is based upon the premise that a clinically effective cell mediated immune response against gastrointestinal, breast, and lung cancers which express the tumor associated antigen CEA can be elicited by activation of CEA-specific cytotoxic T cells (CTL). This protocol proposes a phase I clinical trial to examine the safety and feasibility of the intravenous administration of autologous peripheral blood precursor derived dendritic cells (DC) pulsed with a peptide representing an HLA A-2 restricted CEA CTL epitope to induce CTL in HLA-A2 patients with locally advanced or metastatic CEA- expressing malignancies which have been refractory to conventional therapy. Study Design: This protocol proposes an open label, uncontrolled dose escalating pilot study with a three tiered dose escalation strategy. The highest dose to be tested corresponds to the largest number of DC that can be generated from mononuclear cells harvested from peripheral blood isolated by a routine leukapheresis. All patients will be evaluated for dose-limiting toxicity and immune responses to therapy.
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