Overview

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

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan Cancer Center
University of Michigan Rogel Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Tretinoin
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