UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia (IRB 1996-0189)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer; Precancerous/Nonmalignant Condition	Drug: tretinoin	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Allocation:	Randomized
Primary Purpose:	Prevention
Official Title:	Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial
Study Start Date :	January 1999
Actual Primary Completion Date :	March 2001
Actual Study Completion Date :	November 2009

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	14 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

University of Michigan Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Mack T. Ruffin, MD, MPH	University of Michigan Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Mack Ruffin, University of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00003598 History of Changes
Other Study ID Numbers:	CDR0000066670; P30CA046592 ( U.S. NIH Grant/Contract ); CCUM-9609; NCI-P98-0131
First Posted:	December 5, 2003
Last Update Posted:	September 22, 2010
Last Verified:	September 2010

Keywords provided by University of Michigan Cancer Center:

cervical cancer; cervical intraepithelial neoplasia grade 2; cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Precancerous Conditions; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms	Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Tretinoin; Antineoplastic Agents; Keratolytic Agents; Dermatologic Agents