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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2002-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin

NCT00601640

Other Benign Neoplasm of Skin, Unspecified

COMPLETED PHASE2

Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

NCT00375739

Actinic Keratosis

COMPLETED PHASE2

Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)

NCT00603798

Actinic Keratosis

COMPLETED PHASE3

Green Tea Extract in Treating Patients With Actinic Keratosis

NCT00005097

Non-melanomatous Skin Cancer

TERMINATED PHASE2

Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel

NCT00239135

Keratosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-melanomatous Skin Cancer Precancerous/Nonmalignant Condition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eflornithine

Intervention Type DRUG

triamcinolone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No