Clinical Background

Malignant melanoma, the most aggressive skin cancer withrap-idly rising incidence over recent decades, may be curable when resected at an early stage. In its metastatic stage, melanoma is highly resistant to standard forms of therapy (e.g., surgery, chemotherapy) and causes substantial mortality (33-35).

Given the putative role of the host immune system, and particularly the cell-mediated immunity in the pathogenesis of melanoma and in containing tumor growth, many attempts have been made to amplify host antitumor immune responses, such as regional or systemic administration of a variety of biological response modifiers (e.g., BCG, immunostimulatory cytokines, IL-2, IFN-a) and the use of various vaccines consisting of intact tumor cells/cell extracts (36-39). Although these treatment modalities induced impressive tumor regression in a subset of selected patients with metastatic melanomas, overall results were disappointing. Thus, it is imperative that new approaches—therapeutically effective but low toxic—are continued to be explored.

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