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

Cervical Cancer Clinical Trial

— IRB 1996-0189  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003598
• Other study ID #: CDR0000066670
• Secondary ID: P30CA046592CCUM-
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: September 20, 2010
• Start date: January 1999
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2009
• Est. primary completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Uterine Cervical Neoplasms

Intervention

Drug:
• tretinoin

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,