Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
Condition: Precancerous Condition
MeSH terms: Precancerous Conditions
Intervention: perillyl alcohol; placebo
Intervention description: Applied as topical cream; Applied as topical cream
Intervention MeSH terms: Perillyl alcohol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratosis

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Resident of Pima or adjoining Southern Arizona county

               -  Patients outside of Pima County are also eligible

          -  Sun damaged skin as judged by the study physician and quantifiable, clinically
             diagnosed, and visible actinic keratoses (AK) on both dorsal forearms, with at least
             two AK on each arm

               -  AK lesions must not be clustered, confluent, or too numerous to count accurately

               -  Presence of AK on sites other than the test area allowed

          -  No significant inflammation or irritation of the skin of the upper extremities that is
             not clinically diagnosed as sun damage or AK

          -  Patients must agree to limit sun exposure as much as possible and may continue their
             normal pattern of sunscreen use

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Females must not be of childbearing potential, and therefore must be post-menopausal
             or surgically sterile by hysterectomy

          -  Not pregnant or nursing

        Exclusion criteria:

          -  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