Overview
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
Status:
Completed
Completed
Trial end date:
2014-12-01
2014-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of ArizonaCollaborator:
National Cancer Institute (NCI)Treatments:
Diclofenac
Eflornithine
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.