Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Prevention	Closed	Over 14	NCI	CCUM-9609 NCI-P98-0131, NCT00003598

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.

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
 

Expected Enrollment

A total of 180 patients (45 per arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Mack T. Ruffin, MD, MPH, Protocol chair		Ph: 734-998-7120; 800-865-1125 Email: mruffin@umich.edu

Registry Information
Official Title		Retinoids and Intermediate Biomarkers for CIN II and III: Pilot Trial
Trial Start Date		1999-01-20
Registered in ClinicalTrials.gov		NCT00003598
Date Submitted to PDQ		1998-09-25
Information Last Verified		2007-05-21
NCI Grant/Contract Number		CA46592

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