Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Prevention	Closed	40 to 75		DCPC-CPSB-10305

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 Contact Information

Trial Lead Organizations

NCI - Cancer Prevention Studies Branch

Joseph Tangrea, MPH, Protocol chair		Ph: 301-496-8559