title: Phase I trial of retinol in cancer patients.
abstract: Vitamin A (all-trans-retinol) and its analogues are undergoing evaluation as antineoplastic and chemoprevention agents. Because its toxicity and activity are poorly defined, we have completed a phase I trial of retinol. Retinol was administered to 13 cancer patients in daily doses ranging from 100,000 units/m2 to 350,000 units/m2. Neuropsychiatric changes were the earliest dose-limiting symptomatic toxicities, noted in 3 of 5 patients receiving more than 240,000 U/m2 for 3-4 months. Two patients receiving more than 270,000 U/m2 developed hepatomegaly after 3 and 4 months. Liver biopsies were consistent with vitamin A toxicity. Three patients receiving 200,000 U/m2 developed an increase in serum triglycerides concentration. Mild skin and mucous membrane dryness occurred in most patients receiving more than 150,000 U/m2. A mixed response was seen in one patient with melanoma. Because of neuropsychiatric and hepatic toxicity a retinol dose of 200,000 U/m2/day is recommended for future phase II trials.
mesh_terms: D000328:Adult; D000368:Aged; D002277:Carcinoma / Q000188:drug therapy; D003110:Colonic Neoplasms / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006261:Headache / Q000139:chemically induced; D006529:Hepatomegaly / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000473:pathology; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011877:Radionuclide Imaging; D012871:Skin Diseases / Q000139:chemically induced; D014801:Vitamin A / Q000009:adverse effects* / Q000633:toxicity; D014987:Xerostomia / Q000139:chemically induced
chemical_list: D014801:Vitamin A