Abstract
2582 Background: We have previously demonstrated in phase I clinical trial treating 20 patients with metastatic melanoma that dendritic cells (DCs) loaded with killed allogeneic tumor cells can elicit immune and clinical responses. In that study DCs were generated from monocytes with GM-CSF and IL-4 and activated with a combination of TNF and soluble CD40 ligand. Two patients who had failed previous therapy including DTIC, achieved durable objective clinical responses, one CR and one PR lasting ≥ 20 months. We describe here the development of a high-throughput method for generating DC vaccines with improved immunogenicity and preliminary data from their evaluation in a Phase II trial in metastatic melanoma. Methods: We have initiated a phase II clinical trial (IRB #005–065; BB-IND #12339) enrolling patients with stage IV melanoma who failed first line therapy with DTIC and/or temozolomide with or without IL-2. Patients will receive seven injections of an autologous DC vaccine generated from monocytes by culturing with GM-CSF and Type I interferon and loaded with heat-treated and killed allogeneic Colo829 melanoma cells. Vaccine is generated in a closed system and stored frozen. Patients are vaccinated over 18 weeks. The trial is based on an initial toxicity evaluation in the first 10 patients on top of a 2-stage response rule - 1/19 to continue and 5/30 to accept. The trial is expected to accrue a total of 32 subjects. The primary end-points of this trial are the rate of objective clinical response and the safety/feasibility of the vaccination preparation. Results: To date seven patients were enrolled and begun vaccinations. Vaccine has been successfully generated for all enrolled patients. Thus far, a total of 20 vaccinations have been administered. Vaccinations were safe and tolerable. [Table: see text]
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