Cervical Cancer Clinical Trial
Official title:
Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial
RATIONALE: Tretinoin may help cervical neoplasia cells develop into normal cervical cells.
It is not yet known whether tretinoin is more effective than a placebo in preventing
cervical cancer in patients with cervical neoplasia.
PURPOSE: Randomized clinical trial to study the effectiveness of tretinoin in preventing
cervical neoplasia from developing into cervical cancer.
OBJECTIVES: I. Determine whether topical tretinoin reduces the number of viral genome copies
of human papilloma virus (HPV) per cell and inhibits HPV E6/E7 gene expression in patients
with cervical dysplasia. II. Determine the dose of tretinoin for use in a definitive trial
that produces the best overall modulation of these biomarkers.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
cervical intraepithelial neoplasia classification (II vs III). Patients are randomized to 1
of 4 arms. Arm I: Patients receive low-dose tretinoin topically via cervical cap and
polyurethane ether foam sponge changed daily for 4 days. Arm II: Patients receive
intermediate-dose tretinoin as in arm I. Arm III: Patients receive high-dose tretinoin as in
arm I. Arm IV: Patients receive placebo topically as in arm I therapy. Patients are followed
for 6 months.
PROJECTED ACCRUAL: A total of 180 patients (45 per arm) will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Prevention
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