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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer, Precancerous/Nonmalignant Condition

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Trial Information

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


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000068767

NCT ID:

NCT00021294

Start Date:

May 2001

Completion Date:

June 2002

Related Keywords:

  • Non-melanomatous Skin Cancer
  • Precancerous/Nonmalignant Condition
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • actinic keratosis
  • Skin Neoplasms
  • Keratosis
  • Keratosis, Actinic
  • Precancerous Conditions

Name

Location

Arizona Cancer CenterTucson, Arizona  85724