The hypothesis being tested in this protocol is to determine if T cell reactivity can be induced by the administration of vaccines composed of autologous tumor cells transduced to secrete GM-CSF. Patients with stage IV melanoma undergo retrieval of tumor for retroviral transduction with a gene encoding human GM-CSF. The vaccine is administered and one week later, vaccine-draining lymph nodes are removed to assess T cell reactivity to autologous tumor. In addition, these lymph nodes are activated ex vivo and subsequently transferred back to patients along with the administration of IL-2 for therapy. To date, we have entered four patients. Excision of the vaccine sites at the time of lymph node harvest has revealed dramatic recruitment of dendritic cells to the vaccine site induced by the secretion of GM-CSF. One of four patients has manifested a partial response of distant metastases. The study is currently ongoing.
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