Somatic gene therapy of human melanoma: preclinical studies and early clinical trials.

Several clinical trials of gene therapy of melanoma have been initiated during the last few years. This review examines the rationale of these studies and the different strategies that have been adopted to translate the preclinical results into clinical protocols. Animal studies with mouse melanomas are briefly reviewed to assess the therapeutic potential of different strategies of gene therapy. It has been shown that cytokine gene-modified mouse melanoma cells may induce an immune response resulting in tumour growth delay or even cure of tumour-bearing animals. In addition, normal cells modified to release cytokines and admixed with autologous tumour cells have shown some immunotherapeutic activity. Other strategies appear to be at an earlier phase of investigation in melanoma. The advantages and disadvantages of the different approaches in clinical trials of gene therapy of human melanomas are also assessed. Although no conclusive clinical data are yet available, the large number of ongoing studies will shortly provide us with more results to evaluate critically the effectiveness and future developments of the gene therapy of human melanoma.