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
  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:


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

Additional Information:
No publications provided

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:
Precancerous Conditions
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Tretinoin
Antineoplastic Agents
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014