A propspective clinical trial of difluoromethylornithine (DFMO) in patients with resected superficial bladder cancer

Difluoromethylornithine (DFMO) is a promising chemopreventive agent which is exerted unchange in the urine, is active in vivo against superficila bladder cancer in animal tumor model systems, and has cytotoxic activity in vitro aginst superficial bladder cancer cells. Thus, DFMO may be particularly efficacious in preventing the development of bladder tumors and/or the therapy of established superficial bladder cancer. To examine this hypothesis, an intergroup clinical trial is currently accuring patients with cystoscopically respected superficial bladder cancer (who would otherwise simply be observed).While the primary goal of this protocol is to define a daily dopse of DFMO having little or no toxicity for use in future randomized chemoprevention trials, the rate of recurrent bladder tumors will also be followed in the hope that DFMO will inhibit the development of recurrent bladder cancders. © 1992 Wiley‐Liss, Inc.