Phase I study of 13-cis-retinoic acid toxicity.
A phase I study of 13-cis-retinoic acid was done in 16 patients with head and neck malignancies using a modified Fibonacci search scheme, with individual doses ranging from 20 to 120 mg/m2. Drug doses greater than 60 mg/m2 induced intense headaches, urethritis, desquamative dermatitis, vertigo, and ataxia. The severity of these side effects precludes the use of 13-cis-retinoic acid as a potential chemopreventive agent at doses greater than 60 mg/m2.
D000328:Adult; D000368:Aged; D002613:Cheilitis / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007057:Ichthyosis / Q000139:chemically induced; D007536:Isomerism; D008297:Male; D008875:Middle Aged; D014212:Tretinoin / Q000009:adverse effects*; D014526:Urethritis / Q000139:chemically induced
D014212:Tretinoin