Phase I study to the immunotherapy of metastatic malignant melanoma by a cancer vaccine consisting of autologous cancer cells transfected with the human IL-2 gene
Vienna: 30 November 1994 Würzburg: 7 February 1995 Freiburg: 7 February 1995 Registration of protocol with state authority AMB: 7 November 1994 Bfarm: 30 October 1994 Registration of product with federal authority (Paul-Ehrlich-Institut) 30 December 1994 Therapeutic gene Human interleukin-2 Regulatory element(s) CMV promoter Vector constructed by Institute of Molecular Pathology, Vienna, Austria Vector produced by Bender & Co., Vienna, Austria Transfer method Receptor-mediated, adenovirus enhanced gene transfer (transferinfection) in vitro Packaging cells N/A Target cells Autologous human malignant melanoma cells Indication Metastatic malignant melanoma (stage IV) First patient enrolled 15 December 1994 (Vienna) Patient number 12 evaluable patients Expected accrual rate 3 patients per month