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

14 Years
Not Enrolling
Cervical Cancer, Precancerous/Nonmalignant Condition

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Trial Information

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

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven cervical dysplasia (cervical
intraepithelial neoplasia II or III) Lesions must be delineated after colposcopic biopsy
No pap smears suspicious for invasive carcinoma No positive endocervical curettage

PATIENT CHARACTERISTICS: Age: Over 14 Performance status: Karnofsky 80-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Immunologic: No proliferative skin disorder (e.g., psoriasis) No diagnosed
autoimmune disorders No allergy to tretinoin or latex Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception (except
intrauterine device) during and for 3 months after study Normal diet with adequate protein
and carbohydrate intake No in-utero exposure to diethylstilbesterol No prior malignancy No
prior toxic shock syndrome

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 week
since prior tretinoin No prior retinoids (greater than 25,000 IU vitamin A or equivalent
for at least 3 months) No other tretinoin during or for 3 months after study Endocrine
therapy: No concurrent regular steroids Radiotherapy: Not specified Surgery: See Disease
Characteristics Other: No concurrent regular anticoagulant medication No concurrent
nutritional supplements other than 2 multivitamins per day

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Mack T. Ruffin, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

November 2009

Related Keywords:

  • Cervical Cancer
  • Precancerous/Nonmalignant Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752