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	21 to less than 85		UARIZ-P89-0002 NCI-P89-0002

Objectives

I.  Compare the effectiveness of isotretinoin vs. vitamin A vs. placebo in the 
prevention of basal or squamous cell cancer of the skin in patients who have 
had four or more of these lesions resected previously.
II.  Compare the incidence and time to development of subsequent basal or 
squamous cell skin cancers among these treatment groups.
III.  Determine the rate of protocol compliance.
IV.  Determine the incidence, type, and degree of toxicity of these treatments 
in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between 21 and 85 years of 
age with a history of four or more biopsy-proven basal and/or squamous cell 
carcinomas of the skin, one of which was resected within the previous 12 
months.  Prior biopsy pathology reports must be available for review; a 
clinical diagnosis of basal cell nevus syndrome or xeroderma pigmentosum 
excludes.  Patients taking vitmamin A supplements in amounts exceeding 10,000 
units/day must be willing to discontinue their use while on study.  The 
following laboratory parameters must be met:  WBC at least 4,000, platelets at 
least 100,000, and Hgb at least 14 in men and 12 in women; SGOT no more than 
50 U/liter and SGPT no more than 55 U/liter; and cholesterol no more than 275 
mg/dl and triglycerides within normal ranges for age and sex.  Patients who 
have undergone treatment for or have a history of any other malignancy are 
excluded.  Women must not be of childbearing potential (i.e., naturally 
postmenopausal or surgically sterile) and must not be breast-feeding a child.  
Patients must anticipate residing in southern Arizona for the succeeding 5 
years and must be willing to return for examination 4 times/year during the 
study period.

Expected Enrollment

498 subjects (166 per arm) will be entered; an accrual rate of 12.5 
subjects/month is anticipated.  If at interim analysis one arm is clearly 
inferior to the others (significant to 3 standard deviations), accrual will 
cease.

Outline

Randomized double-blind study.  Initially, all patients are given a placebo 
for 3 months; after this time, those who wish to continue on study and who 
have taken at least 75% of the supplied capsules are randomized to one of the 
treatment arms.
Arm I:  Chemoprevention.  Isotretinoin, 13-cis-Retinoic Acid, 13-CRA, 
NSC-329481.
Arm II:  Chemoprevention.  Vitamin A, NSC-122759.
Arm III:  Control.  Placebo.

Trial Contact Information

Trial Lead Organizations

Arizona Cancer Center at University of Arizona Health Sciences Center

Norman Levine, MD, Protocol chair		Ph: 520-699-0668; 800-622-2673 Email: nlevine@u.arizona.edu