Clinical Trials Directory

Trials / Completed

CompletedNCT00003598

UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia

Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
University of Michigan Rogel Cancer Center · Academic / Other
Sex
Female
Age
14 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGtretinoin

Timeline

Start date
1999-01-01
Primary completion
2001-03-01
Completion
2009-11-01
First posted
2003-12-05
Last updated
2010-09-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00003598. Inclusion in this directory is not an endorsement.