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

This study has been completed.
Sponsor:
Collaborator:
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

November 1, 1999
September 20, 2010
January 1999
March 2001   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003598 on ClinicalTrials.gov Archive Site
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UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia
Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Prevention
  • Cervical Cancer
  • Precancerous/Nonmalignant Condition
Drug: tretinoin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2009
March 2001   (final data collection date for primary outcome measure)

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

Female
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003598
CDR0000066670, P30CA046592, CCUM-9609, NCI-P98-0131
Yes
Dr. Mack Ruffin, University of Michigan Comprehensive Cancer Center
University of Michigan Cancer Center
National Cancer Institute (NCI)
Study Chair: Mack T. Ruffin, MD, MPH University of Michigan Cancer Center
University of Michigan Cancer Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP