RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.

Condition	Treatment or Intervention	Phase
actinic keratosis squamous cell carcinoma of the skin prevention of skin cancer basal cell carcinoma of the skin	Procedure: chemotherapy  Procedure: hormone therapy  Procedure: steroid therapy  Drug: chemoprevention of cancer  Procedure: endocrine therapy  Procedure: cancer prevention intervention  Drug: eflornithine  Drug: triamcinolone	Phase II

Further Study Details: 

OBJECTIVES: I. Compare the safety and efficacy of eflornithine (DFMO) vs placebo as chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic keratosis (AK). II. Determine whether this drug reverses AK in these patients. III. Determine whether triamcinolone reduces DFMO-induced skin irritation in these patients.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive eflornithine (DFMO) topically and triamcinolone topically to forearms once daily. Arm II: Patients receive DFMO and placebo topically as in arm I. Arm III: Patients receive placebo and triamcinolone topically as in arm I. Arm IV: Patients receive 2 placebos topically as in arm I. Treatment continues for 6 months in the absence of unacceptable toxicity. Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 1 year.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of actinic keratosis; At least 3 clinically visible lesions on each lower posterior forearm; Lesions must be discrete and quantifiable
• No prior or concurrent skin cancer on forearms; Prior skin cancer (other than melanoma) on an area other than the forearms allowed unless chronic recurrent lesions indicate immunosuppression; Concurrent skin cancer on an area other than the forearms allowed if active lesion previously excised

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 5 years since prior systemic chemotherapy; At least 6 months since prior fluorouracil (5-FU) to forearms; Prior or concurrent 5-FU to the face allowed
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: See Disease Characteristics
• Other: At least 30 days since prior megadoses of vitamins (e.g., more than 400 IU of vitamin E, 200 micrograms of selenium, or 1 g of vitamin C per day or more than the tolerable upper limits of any other supplement); At least 6 months since prior tretinoin to forearms; Prior or concurrent tretinoin to the face allowed; No concurrent mega-doses of vitamins; No other concurrent investigational drug or device

--Patient Characteristics--

• Age: 18 and over
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: No serious concurrent illness; No immunosuppression due to medication or disease; No invasive cancer (including melanoma) within the past 5 years; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception at least 28 days prior to and during study

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

Study chairs or principal investigators

David Samuel Alberts,  Study Chair,  Arizona Cancer Center   

Study ID Numbers:  CDR0000068767; UARIZ-HSC-0072; NCI-H01-0075
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021294
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08