Progress reports on immune gene therapy for stage IV renal cell cancer using lethally irradiated granulocyte-macrophage colony-stimulating factor-transduced autologous renal cancer cells

There is no effective treatment for patients with stage IV renal cell cance r (RCC), although the introduction of nt tv therapy is imminent. Cancer gen e therapy is currently considered to be one of the most promising therapeut ic modalities in the field of cancer treatment. Based on the results of ani mal studies, vaccination using autologous granulocyte-macrophage colony-sti mulating factor-transduced renal cancer cells appears promising. Before ini tiating a clinical study using an ex vivo gene-transduced autologous cell v accine-based immunogene therapy for RCC in Japan, in 1992 we initially plan ned a Japanese version of a clinical protocol in collaboration with a US gr oup. In 1993, the original protocol was refined. We performed five preclini cal qualification studies using RCC nephrectomy specimens from patients in 1997, and the results showed that preparation of RCC cells for autologous v accines at the Clinical Cell Technology Facility, Research Hospital of the Institute of Medical Science, University of Tokyo, was feasible. Subsequent ly in August 1998, the Ministry of Health and Welfare and the Ministry of E ducation, Science, Culture, and Sport approved our clinical protocol. We ha ve recruited two patients with stage IV RCC to our study so far. Here we re port the background to the initiation of cancer gene therapy in Japan.