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Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial (NCT00003598)

National Cancer Institute (NCI)
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.
  • Drug: tretinoin
    Ages eligible for Study
    14 Years and older
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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.

    1 locations

    United States (1)
    • University of Michigan Comprehensive Cancer Center
      Not specified
      Ann Arbor, Michigan, United States, 48109-0752
    Status:
    completed
    Type:
    Interventional
    Phase:
    -
    Start:
    31 December, 1998
    Updated:
    19 September, 2010
    Participants:
    180
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