Abstract

7559 Background: GM-CSF leads to dendritic cell priming and activation, and also increases IL-2 receptor expression on T-lymphocytes. IL-2 creates LAK cells and TIL cells. Therefore, it was compelling to combine these 2 agents, each with a different function but a complimentary action. Methods: This is an open label, single arm study. 16 patients participated and underwent potentially curative surgery. Post-operatively, each patient received GM-CSF: 125μgm/m2/day, sc ×14 days; followed by IL-2: 9 million IU/m2/day, sc ×4 days, then 10 –12 days of no treatment. This cycle was repeated once/month for 6 months, i.e., 6 cycles. In addition, patients with large tumors received autologous melanoma vaccine. All the patients were observed, and in the event of recurrence or metastases, the patient was evaluated for resection and was re-treated on the same program. Results: The patient population consisted of: 8 patients with T3b-T4b primary melanoma. The remaining 8 patients had metastases to regional lymph nodes ...

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