A phase II study of ifosfamide in the treatment of relapses in Wilms' tumor.

The purpose of this study was to evaluate the antitumor activity and tolerability of ifosfamide (IFO) at a dose of 3 g/m2, given on 2 consecutive days every 2 weeks, in advanced Wilms' tumor patients in whom conventional therapy had failed. Mesna and hyperhydration were concomitantly given to minimize bladder toxicity. A total of 21 patients with advanced Wilms' tumor were entered in the study. The response observed after two courses was complete in 6 patients and partial in 5; 10 did not respond; the median duration of response was 2 months (range, 1-7 months). Leucopenia caused a delay in therapy for 1 or 2 weeks in only three cases. Neither fever nor infection were observed. Of 7 patients who developed hematuria, 3 were among the 17 who concurrently received mesna. The urotoxicity did not interfere with subsequent therapy in these three cases.