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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

University of Michigan Cancer Center

ClinicalTrials.gov Identifier:

NCT00003598

First received: November 1, 1999

Last updated: September 20, 2010

Last verified: September 2010

History of Changes

Purpose

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	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Drug: tretinoin


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Prevention
Official Title:	Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Tretinoin

Genetic and Rare Diseases Information Center resources: Cervical Intraepithelial Neoplasia

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:


Estimated Enrollment:	180
Study Start Date:	January 1999
Study Completion Date:	November 2009
Primary Completion Date:	March 2001 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	14 Years and older (Child, Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003598

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


Responsible Party:	Dr. Mack Ruffin, University of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00003598 History of Changes
Other Study ID Numbers:	CDR0000066670 P30CA046592 CCUM-9609 NCI-P98-0131
Study First Received:	November 1, 1999
Last Updated:	September 20, 2010
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 26, 2016

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