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



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

For Condition: Cervical Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Michigan Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:  Interventional, Prevention
Minimum Age/Maximum Age: 14 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MackRuffin,  Study Chair,  University of Michigan Comprehensive Cancer Center

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


Additional Information:
Study ID Numbers:  CDR0000066670;  CCUM-9609,NCI-P98-0131
Study Start Date: January 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003598

Other Cervical Cancer Studies:
1. SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia

2. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma

3. Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter

4. SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

5. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

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