Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
Condition: Other Benign Neoplasm of Skin, Unspecified
MeSH terms: Neoplasms; Skin Neoplasms
Intervention: Diclofenac Na gel; Eflornithine HCL ointment
Intervention description: Given topically twice daily on days 1-90; Given topically twice daily on days 1-90
Intervention MeSH terms: Eflornithine; Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: skin cancer

Summary:

      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
      of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged
      skin.

      PURPOSE: This randomized phase II trial is studying the side effects and how well
      eflornithine works compared with diclofenac, given alone or together, in treating patients
      with sun-damaged skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visible sun-induced damage to the skin as assessed by the study dermatologists

          -  No inflammation of the skin on the lateral forearms

          -  No more than 10 actinic keratoses on the left forearm, and no actinic keratoses in the
             treatment area

          -  Resident of Pima or an adjoining Southern Arizona county

          -  History of treated basal cell carcinoma and/or squamous cell carcinoma of the skin at
             any site other than the left forearm allowed if excision or topical treatment was
             completed more than 30 days ago (60 days for radiotherapy)

          -  History of treated basal cell carcinoma and/or squamous cell carcinoma of the skin on
             the left forearm allowed 6 months after treatment is completed

          -  Must agree to avoid sun exposure to the left forearm as much as possible

          -  Not pregnant or nursing

          -  Not moderately to highly immunosuppressed by virtue of medication or disease, except
             for mildly suppressive disorders (e.g., diabetes mellitus or on mildly
             immunosuppressive therapy such as inhaled steroids for asthma)

          -  No serious concurrent illness that could interfere with study participation

          -  No active peptic ulcer disease, bleeding disorder, renal failure (creatinine > 2.0
             mg/dL), or porphyria

          -  No known hypersensitivity to diclofenac sodium, eflornithine, acetylsalicylic acid, or
             NSAIDS

          -  No evidence of serious underlying medical conditions as demonstrated by abnormal
             values on baseline laboratory assessment

          -  More than 6 months since prior chemotherapy and in complete remission

          -  More than 60 days since prior and no concurrent oral diclofenac sodium (Cataflam®,
             Voltaren®, Voltaren-XR®) or combination of diclofenac and misoprostol (Arthrotec®)

          -  More than 60 days since prior and no concurrent IV eflornithine hydrochloride

          -  More than 30 days since prior and no concurrent topical retinoids, steroids, imiquimod
             (Aldara®), aminolevulinic acid HCl (Levulan®), eflornithine (Vaniqa®), diclofenac
             sodium gel (Solaraze®), or fluorouracil at any site

          -  More than 30 days since prior and no concurrent topical medication, other than
             emollients or sunscreens, on the left forearm

          -  Not undergoing concurrent bone marrow or solid organ transplant

          -  No concurrent immunosuppressive therapy (e.g., systemic chemotherapy or rheumatologic
             agents such as infliximab [Remicade®])

          -  No concurrent sunscreen use to the left forearm

          -  No concurrent active therapy for any invasive cancer

          -  No concurrent NSAIDs for more than 14 days per month for arthritic and other pain
             conditions

          -  Concurrent prednisone or other steroids with doses up to 20 mg/day (or the equivalent
             dose) allowed

          -  At least 30 days since prior and no concurrent enrollment on other investigational
             drug or device trial

        Exclusion Criteria:

          -  Individuals receiving concurrent topical therapy with retinoids, steroids,
             5-fluorouracil, Levulan, Vaniqa (eflornithine), Solaraze, or Imiquimod (Aldara®)
             within 30 days prior to study enrollment will be excluded. Subjects may be
             reconsidered for eligibility 30 days after the last topical treatment.

          -  Individuals who have had treatment for basal cell carcinoma or squamous cell carcinoma
             of the skin of the left forearm within six months prior to evaluation for the study
             will not be eligible. If interested, these subjects will be encouraged to return for
             re-evaluation once the six-month period is over.

          -  Individuals who are moderately to highly immunosuppressed by virtue of medication or
             disease will not be allowed to participate. This category includes individuals
             undergoing bone marrow or solid organ transplant, or receiving immunosuppressive
             therapy such as systemic chemotherapy or rheumatologic agents such as infliximab
             (Remicade®). However, individuals with mildly suppressive disorders such as diabetes
             mellitus or on mildly immunosuppressive therapy such as inhaled steroids for asthma
             will be eligible for participation. Doses up to 20 mg of prednisone per day or the
             equivalent dose of other steroids will be allowed.