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Phase III Randomized Evaluation of Isotretinoin for the Prevention of Basal Cell Carcinoma in a High-Risk Population (Summary Last Modified 08/88)
Basic Trial Information
Objectives I. Evaluate the effectiveness of low dose levels of isotretinoin in reducing the incidence of basal cell carcinoma in a high-risk population. II. Examine the possible side effects associated with long-term administration of low doses of isotretinoin. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: White men and women between the ages of 40 and 75 who have had two or more biopsy-proven basal cell carcinomas during the 5 years prior to entry as verified by the following: two pathology records of positive biopsies of separate sites, presentation with two confirmed basal cell carcinomas at separate sites, or presentation with a confirmed basal cell carcinoma in addition to one previous pathology record of positive biopsy. Use of isotretinoin within one year or use of 5-fluorouracil or tretinoin within 6 months of randomization excludes. Patients must have normal hepatic and renal function as demonstrated by total bilirubin less than 1.5 mg%, SGOT less than 60 or within normal limits for the institution, serum creatinine less then 1.7 mg%, and BUN less than 27 mg%. The entire skin surface must be evaluable for the presence of basal cell carcinoma, and patients must be willing to seek appropriate definitive treatment for basal cell cancers that arise during the study. Patients must be willing and able to participate for the duration of the study (3 years outpatient treatment and 2 years follow-up) and agree not to take high-dose vitamin A (more than 5,000 units/day) for the duration of the intervention phase of the study. Participation in any other studies that may interfere with this study is not allowed. The following exclude: known history of basal cell nevus syndrome, xeroderma pigmentosum, or psoriasis; hypersensitivity to retinoids and/or parabens; or generalized exfoliative erythroderma at the time of entry. Current evidence of hyperlipidemia or hypercholesterolemia (fasting serum cholesterol greater than 350 mg% and/or triglycerides greater than 210 mg%) excludes; two successive triglycerides less than 211 mg% within 3 months of randomization are required. Patients with severe coronary artery disease (New York Heart Association class III-IV) or proven active malignancy, other than nonmetastatic basal cell or squamous cell carcinoma, within 5 years of randomization are ineligible. Women must be incapable of childbearing (surgical menopause, tubal ligation at least one year prior to randomization, or no menses for at least one year). Expected Enrollment 1,224 patients will be randomized. Outline Randomized study. Arm I: Single-agent Chemoprevention. 13-cis-Retinoic acid, Isotretinoin, NSC-329481. Arm II: No Chemoprevention. Placebo. Trial Lead Organizations NCI - Cancer Prevention Studies Branch
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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