The prevention or therapeutic reversal of preneoplasias in humans has been little studied. Cervical intraepithelial neoplasia (cervical dysplasia) represents an excellent model to study preneoplasia inasmuch as the lesions can be safely and easily monitored in response to an intervention and therapeutic agents can be delivered locally, thereby obviating systemic side-effects. We have developed a simple delivery device consisting of a cervical cap and collagen sponge which allows constant exposure of the therapeutic agent to the cervix. We have conducted phase I toxicity and phase II efficacy trials using the retinoid beta-all-trans retinoic acid. The results were sufficiently encouraging that we have planned a stratified, randomized trial (cancer control phase III) of beta-all-trans retinoic acid versus placebo cream in a total of 300 patients with moderate and severe dysplasia. This application seeks support for continuation of this trial.
| Meyskens Jr, F L; Surwit, E; Moon, T E et al. (1994) Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial. J Natl Cancer Inst 86:539-43 |
| Loescher, L J; Graham, V E; Aickin, M et al. (1990) Development of a contingency recruitment plan for a phase III chemoprevention trial of cervical dysplasia. Prog Clin Biol Res 339:151-63 |
| Aickin, M (1990) Maximum likelihood estimation of agreement in the constant predictive probability model, and its relation to Cohen's kappa. Biometrics 46:293-302 |
| Graham, V; Surwit, E S; Weiner, S et al. (1986) Phase II trial of beta-all-trans-retinoic acid for cervical intraepithelial neoplasia delivered via a collagen sponge and cervical cap. West J Med 145:192-5 |
