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

NCT00608634 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000582634P01CA027502P30CA023074UARIZ-HSC-04-27UARIZ-POH-002
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Precancerous Condition

Keywords

actinic keratosis

Outcome Measures

Primary Outcomes (1)

• Change in Histopathology Score of Sun Damaged Skin by Treatment Group

  The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 \& 2), 2- inflammation (grades 0, 1 \& 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were \>3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of \>3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.

  Baseline to 3 months

Secondary Outcomes (1)

• Skin Related Events From Perillyl Alcohol at Administered Doses by Participants

  3 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: placebo

Low Dose POH 0.30%

EXPERIMENTAL

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

Drug: perillyl alcohol

High Dose POH 0.76%

EXPERIMENTAL

Patients apply perillyl alcohol (POH) cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.

Drug: perillyl alcohol

Interventions

perillyl alcohol DRUG

Applied as topical cream

High Dose POH 0.76%; Low Dose POH 0.30%

placebo OTHER

Applied as topical cream

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• IU of vitamin E
• μg of selenium
• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator
• Arizona Disease Control Research Commission: collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Precancerous Conditions; Keratosis, Actinic

Interventions

perillyl alcohol

Condition Hierarchy (Ancestors)

Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Steven P. Stratton, PhD
• Organization: Arizona Cancer Center

sstratton@azcc.arizona.edu

520-626-9295

Study Officials

• Steve Stratton, PhD

  University of Arizona

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 6, 2008
• Study Start: May 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2009
• Last Updated: April 1, 2015
• Results First Posted: April 1, 2015

Record last verified: 2014-03

Locations

US (1)