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

Primary Purpose

Cervical Cancer, Precancerous/Nonmalignant Condition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tretinoin
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 20, 2010
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003598
Brief Title
UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia
Acronym
IRB 1996-0189
Official Title
Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous/Nonmalignant Condition
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tretinoin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mack T. Ruffin, MD, MPH
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States

12. IPD Sharing Statement

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UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia

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