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

2014-08-27 03:33:14 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- To determine if topical administration of perillyl alcohol (POH) cream can reverse actinic damage as evidenced by normalization of quantitative skin histopathology scores in skin tissue biopsy samples from patients with moderate to severe sun damage.

Secondary

- To determine if topically administered POH results in significant alterations in surrogate endpoint biomarkers of epidermal cell proliferation, including optical coherence tomography, p53 expression, c-Fos expression, and apoptosis (as measured by activated caspase-3 expression).

- To determine if topically administered POH results in normalization of nuclear chromatin patterns in skin biopsy tissue from these patients, as determined by karyometric analysis.

- To determine if topical POH can be administered safely to the forearms of these patients.

OUTLINE: Patients are randomized to 1 of 3 arms.

- Arm I: Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.

- Arm II: Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.

- Arm III: Patients apply POH cream (0.76%) as in arm II. Patients undergo tissue sampling of the right or left dorsal forearm and of physician-selected representative actinic keratoses (AK) at baseline and after completion of study therapy. Tissue samples are assessed for changes in patterns of biomarker expression (i.e., p53, apoptosis, c-Fos histopathology) and karyometry. After completion of study therapy, patients undergo tissue sampling of the opposite forearm as well as blood sample collection to determine perillyl alcohol (POH) levels in blood and biopsy samples. Urine is also collected and analyzed for safety at the end of treatment. Digital photographs of the forearms and hands are obtained at baseline and after 3 months of study treatment. Optical coherence tomography imaging is also performed on pre- and post-biopsy sites to quantify the effect of POH on sun damage and AK in skin.

After completion of study treatment, patients are followed monthly.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Precancerous Condition

Intervention

perillyl alcohol, placebo

Location

Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson
Arizona
United States
85724-5024

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:14-0400

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