Abstract

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.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA040889-03
Application #
3548710
Study Section
(SRC)
Project Start
1985-09-15
Project End
1989-08-31
Budget Start
1987-09-01
Budget End
1988-08-31
Support Year
3
Fiscal Year
1987
Total Cost
Indirect Cost

  Institution

Name
University of Arizona
Department
Type
Schools of Medicine
DUNS #
City
Tucson
State
AZ
Country
United States
Zip Code
85722