A PHASE-I TRIAL OF BETA-ALL-TRANS RETINOIC ACID DELIVERED VIA A COLLAGEN SPONGE AND A CERVICAL CAP FOR MILD OR MODERATE INTRAEPITHELIAL CERVICAL NEOPLASIA

  • 1 January 1983
    • journal article
    • research article
    • Vol. 71  (5) , 921-925
Abstract
A phase I trial was conducted of the vitamin A derivative .beta.-all-trans-retinoic acid (vitamin A acid; TRA), delivered via a collagen sponge and cervical cap for mild or moderate intraepithelial cervical neoplasia. On the basis of known skin and mucosal membrane toxicity, a concentration of 0.05% TRA in a cream-based vehicle was selected as the starting dose and was escalated later with the use of a modified Fibonacchi scale. The delivery device and the TRA were changed daily for 4 days, and side effects were assessed on days 1, 2, 3, 4, 8 and 30 by clinical and colposcopic examination. Vaginal, cervical and systemic toxicity were evaluated in 35 patients. No dose-related systemic effects were found; mild cervical inflammation increased in many patients at higher doses. Unacceptably high vaginal toxicity was reached at a TRA concentration of 0.484%. A concentration of 0.372% TRA is recommended for use in phase II trials in mild and moderate cervical intraepithelial neoplasia.