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Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm


Phase 2
40 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

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Trial Information

Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm


OBJECTIVES:

Primary

- To determine if combination therapy with topical eflornithine hydrochloride ointment
and topical diclofenac sodium gel over 3-months increases the efficacy versus either
agent used alone in the treatment of moderately sun-damaged skin.

Secondary

- To evaluate the safety of sequential administration of topical eflornithine
hydrochloride ointment and topical diclofenac sodium gel.

- To determine the correlation of karyometric changes with histopathologic,
immunohistochemical, clinical, and genetic polymorphism data.

- To obtain materials for microarray analysis.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients apply topical eflornithine hydrochloride ointment to their left forearm
twice daily on days 1-90.

- Arm II: Patients apply topical diclofenac sodium gel to their left forearm once daily
on days 1-90.

- Arm III: Patients apply topical eflornithine hydrochloride ointment as in arm I twice
daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.

Prior to treatment, three 4-mm punch biopsies are taken from the skin of the left lateral
forearm for assessment of histopathology, the cyclooxygenase-2 enzyme and p53 expression,
apoptosis, and nuclear chromatin karyometry. Tissue is also obtained for future use in
microarray analysis. Blood is drawn for assessment of ornithine decarboxylase polymorphisms
and for banking for subsequent studies. Biopsies are repeated 2-3 weeks after completion of
treatment.

Digital photographs are taken at baseline and 1-2 weeks after completion of study therapy to
document improvement of sun damage, appearance of new skin lesions, and toxicity.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

- Patients outside of Pima County are eligible but the study will be carried out
in its entirety at the University of Arizona

PATIENT CHARACTERISTICS:

- 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

- Negative pregnancy test

- Fertile patients must use effective contraception

- 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

PRIOR CONCURRENT THERAPY:

- 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 other concurrent topical therapy at any site

- 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 non-steroidal anti-inflammatory drugs (NSAIDs) for more than 14 days
per month for arthritic and other pain conditions

- Concurrent daily aspirin (81-325 mg) or acetaminophen allowed

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Percentage of patients who have 10% or greater reduction in average nuclear abnormality (ANA) as shown by karyometric analysis of skin biopsies before and after treatment

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Joanne M. Jeter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000581429

NCT ID:

NCT00601640

Start Date:

January 2007

Completion Date:

January 2010

Related Keywords:

  • Non-melanomatous Skin Cancer
  • skin cancer
  • Skin Neoplasms

Name

Location

Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260