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2747789 
Journal Article 
Phase IIa study of fenretinide in superficial bladder cancer, using DNA flow cytometry as an intermediate end point 
Decensi, A; Bruno, S; Costantini, M; Torrisi, R; Bruzzi, P; Et al 
1994 
Yes 
Journal of the National Cancer Institute
ISSN: 0027-8874
EISSN: 1460-2105 
IPA/94/1057099 
Natl 
REF 13 
138-140 
English 
IPA COPYRIGHT: ASHP A study evaluating the feasibility of a randomized trial of fenretinide in bladder cancer therapy was conducted based on DNA flow cytometry of serial bladder washings used as an intermediate endpoint and toxicity data obtained from 24 bladder cancer patients, of whom 12 were given 200 mg/day of fenretinide as an oral capsule for 3-37 months and 12 were given a placebo. There was no difference in time to first positive cytology and in recurrence-free survival between patients and controls. Two patients, both in the control group, progressed to invasive cancer. Three patients who received fenretinide complained of diminished dark adaptation, and 4 showed alterations of dark adaptometry. Dermatoses were also observed in 4 patients, but these were mild and transient in nature. It was concluded that the high rate of interpretable flow histograms and the prolonged period of follow-up indicate the feasibility of a larger randomized clinical trial.