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

Alternate Title

Chemoprevention in Patients at High Risk of Developing Skin Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Prevention	Completed	50-84	NCI	MDA-ID-95184 NCI-P97-0099

Objectives

I.  Evaluate the short term safety and biologic activity of chemoprevention 
agents in modulating differentiation, genomic and proliferation markers in 
patients at high risk for nonmelanoma skin cancer.

Entry Criteria

Disease Characteristics:

Patients that are at high risk for nonmelanoma skin cancer by virtue of the
following:
 - History of greater than 10 clinically or pathologically diagnosed actinic
   keratoses (AKs)
 - At least 3 AKs at the enrollment clinic visit
 - History of 0-2 prior pathologically diagnosed cutaneous squamous
   cell carcinoma (SCC) or basal cell carcinoma (BCC), and the availability of
   the tissue block containing the prior SCC

Prior/Concurrent Therapy:

No concurrent vitamin supplements greater than 10,000 IU/day or other
retinoids of any type

Patient Characteristics:

Age:
 50 to 84
 
Weight:
 At least 100 pounds

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 4,000/mm3
 Platelet count at least 140,000/mm3

Hepatic:
 SGOT within normal limits

Renal:
 Not specified

Other:
 Triglyceride no greater than 2 times normal
 No other prior malignancy other than nonmelanoma skin cancer
 No history of basal cell nevus syndrome or xeroderma pigmentosum
 No life threatening disease
 Negative pregnancy test
 Fertile patients must use adequate contraception

Expected Enrollment

Approximately 54 patients will be accrued in this study.

Outline

This is a randomized study.

Patients are randomly assigned to receive one of the following regimens:
- Retinol (ROH) every day OR
- Oltipraz every other day OR
- Isotretinoin every day OR
- ROH and oltipraz every other day OR
- ROH and oltipraz every four days OR
- Retinyl palmitate every day OR
- Fenretinide every day with 3 days off each month OR
- ROH and fenretinide every day OR
- ROH and fenretinide every day (at half dose)

Patients are followed at one month and four months after random allocation.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Scott Lippman, MD, FACP, Protocol chair		Ph: 713-745-3672; 800-392-1611