INTRAVESICAL THERAPY OF SUPERFICIAL BLADDER TRANSITIONAL CELL-CARCINOMA WITH TUMOR-NECROSIS-FACTOR-ALPHA - PRELIMINARY-REPORT OF A PHASE I-II STUDY

A phase I-II trial of intravesical immunotherapy with tumor necrosis factor (TNF)-alpha in 24 patients affected by superficial bladder tumors is herein presented. Of these, 11 patients were submitted, at weekly intervals, after complete TUR, to 8 instillations of TNF-alpha at increasing doses from 50 to 600 mug. Tolerability was excellent. even at the highest dose. In a second group of 13 patients with a histologically proved papillary marker lesion, TNF-alpha was instilled at weekly intervals at the dose of 500 mug for 8 weeks. Three complete responses (23%) were obtained.