[Current status of gene therapy clinical studies for renal cell carcinoma]

Renal cell carcinoma (RCC) has been considered to be one of the immunogenic cancers. There have been published many reports on immune therapy of RCC including 16 immune gene therapy protocols in USA. We have been involved in Phase I clinical trial of immune gene therapy of RCC using GM-CSF(granulocyte macrophage colony stimulating factor) gene-transduced autologous RCC(GVAX-RCC) since 1998. Our results on four stage TV RCC patients demonstrated the safety of this gene therapy. Immunological data suggested the induction of antitumor immune responses by GVAX-RCC. Addition of low dose interleukin-2 (IL-2) was considered to helpful to enhance clinical antitumor response after the vaccinations. Two out of four patients who received GVAX-RCC and low dose IL-2 have been followed up in outpatient clinic for 5.5 years and 4 years, respectively, at PS 0. Based on our clinical study results, new immune gene therapy of RCC combining dendritic cells has been studied in preclinical level.