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

Alternate Title

Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention, Treatment Closed 18 and over NCI UARIZ-HSC-0072 NCI-H01-0075, NCT00021294

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.

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Arizona Cancer Center at University of Arizona Health Sciences Center

David Alberts, MD, Protocol chair		Ph: 520-626-7685; 800-622-2673

Registry Information
Official Title		Phase IIB Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine (DFMO) With and Without a Topical Corticosteroid Cream (Triamcinolone 0.1%) in the Therapy of Actinic Keratoses (AK) on the Forearms
Trial Start Date		2001-05-22
Registered in ClinicalTrials.gov		NCT00021294
Date Submitted to PDQ		2001-05-25
Information Last Verified		2002-04-01
NCI Grant/Contract Number		P01-CA27502, P30-CA23074

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