Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses

Completed · Phase 2 · Has a placebo group

Conditions studied: Precancerous Condition

In brief

RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. It is not yet known which dose of topical perillyl alcohol is more effective in stopping the development of cancer in sun damaged skin. PURPOSE: This randomized phase II trial is studying high-dose topical perillyl alcohol to see how well it works compared with low-dose topical perillyl alcohol in treating patients with sun damaged skin and actinic keratoses.

Key facts

Study ID

NCT00608634

Run by

University of Arizona

People needed

89

Starts

2004-05-01

Expected to finish

2009-06-01

Last updated by the study team

2015-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females must not be of childbearing potential, and therefore must be post-menopausal or surgically sterile by hysterectomy
• Not pregnant or nursing

You may not qualify if…

• Concurrent skin malignancy or disorder of the upper extremities
• Patients with Squamous cell carcinoma or basal cell carcinoma in an area other than the test area are eligible upon excision of the Squamous cell carcinoma or basal cell carcinoma
• Patients who are immunosuppressed by virtue of medication or disease
• Serious concurrent illness that could interfere with study regimen
• Invasive cancer within the past 5 years
• PRIOR CONCURRENT THERAPY:
• At least 30 days since prior topical medications to the skin of the upper extremities except for emollients or sunscreens
• At least 30 days since prior and no concurrent mega-doses of vitamins, defined as any of the following:
• More than 5 times the recommended daily allowance
• More than 5 capsules of multivitamins
• 400 IU of vitamin E
• 200 μg of selenium
• 1 gm of vitamin C
• At least 6 months since prior and no concurrent therapy for squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) anywhere in the test area (i.e., the forearms or hands)
• Treatment for Squamous cell carcinoma or basal cell carcinoma on sites other than the test area is allowed
• At least 4 weeks since prior surgical biopsy, surgical excision, or cryotherapy for AK in the test area and the sites must have healed
• At least 6 months since prior topical treatment (e.g., 5-fluorouracil or imiquimod) for AK
• No concurrent therapy that may interfere with clinical evaluations
• No concurrent topical drug treatment (e.g., retinoids, aminolevulinic acid, diclofenac sodium, imiquimod, or fluorouracil) to any area of skin, including test area
• No concurrent enrollment in another clinical trial
• No concurrent topical citrus peel or consumption of citrus peel
• No chemotherapy for cancer within the past 5 years

Where it is running

• Arizona Cancer Center at University of Arizona Health Sciences Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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