Status:
COMPLETED
Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Non-melanoma Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin ...
Detailed Description
There will be two groups to the study. Individuals, aged 18 years or older, who have extensive actinic damage, at least 8 AKs and a history of at least one non-melanoma skin cancer, but are in otherwi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Previous treatment for basal or squamous cell skin cancer stage 0-2 and current evidence of at least actinic keratosis on the upper extremities (upper arms, forearms and hands), neck, face or scalp.
- \>18 years of age
- Ability to understand and willingness to sign a written informed consent document
- ECOG performance status 0-1
- Willing and able to participate for the full duration of the study
- Willing to abstain from:
- The application of topical medications including prescription and over the counter preparations (e.g., Topical preparations containing corticosteroids or vitamin A derivatives) to intended treatment areas for the duration of the study. Use of moisturizers/emollients and sunscreens on these areas is allowed.
- Chronic (defined as \> 3 times/week for more than 2 consecutive weeks/year) NSAID and COX-2 inhibitor use (other than cardioprotective doses of aspirin \< 100 mg po QD) for the duration of the study
- Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 365 days of registration)
- Hematologic
- WBC \>3,000/ul
- Hemoglobin \> lower limit of normal
- Platelet count \> 100,000/ul
- Hepatic
- Total bilirubin \< 1.5 X ULN
- AST (SGOT) \< 1.5 X ULN
- ALT (SPGT) \< 1.5 X ULN Renal
- Serum creatinine \< 1.5 X ULN BUN \< 1.5 X ULN
- • Females of childbearing potential must:
- Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses
- Have a documented negative urine pregnancy test prior to the first dose of study medication. (Females are not considered to be of childbearing potential if they are at least 1 year post-menopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy)
- The effects of DFMO and diclofenac on the developing fetus are unknown. Therefore, all females of childbearing potential and all men capable of fathering a child must agree to use adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) for the duration of study participation.
- Exclusion Criteria
- Any of the following will render a participant ineligible to participate in this study:
- Aspirin \>100 mg/day
- Chronic (\> 3 times/week for more than a two week period) use of NSAIDs or COX-2 inhibitors
- Current use of topical steroids to intended treatment area (forearms)
- Cryotherapy to intended treatment area (forearms) within the preceding 3 months
- Use of oral or intravenous corticosteroids for more than 2 consecutive weeks
- Any of the following in the 4 weeks prior to randomization:
- Major surgery for any indication
- Cytotoxic chemotherapy for any indication (including methotrexate for arthritis)
- Anti-cancer treatment of any type other than for a stage 0-2 non-melanoma skin cancer
- Hormonal therapy for cancer prevention ((treatment with finasteride/dutasteride for BPH does not render a participant ineligible.)
- Radiation therapy
- Any of the following in the 6 month prior to randomization to the intended treatment area (forearms):
- Topical medications for the treatment of actinic keratosis or skin cancer (etretinate, 5-FU, imiquimod, ingenol)
- Laser resurfacing, dermabrasion, chemical peel and/or electrodissection ± curettage
- Any family history of Ornithine diaminotransferase deficiency in a first degree relative
- Any personal history of:
- Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for \>5 years and have not required treatment in the past 5 years may be eligible if a study chair or principal investigator believes there is little to no risk of recurrence.
- Solid organ or bone marrow transplant
- Biopsy proven hepatic cirrhosis
- Keloid formation
- Photosensitivity disorder
- Hypersensitivity or adverse reactions to nonsteroidal anti-inflammatory agents
- Oral DFMO for \> 1 month on a prior study
- Any disease that predisposes to NMSC
- An immunodeficiency disorder or the use of an immunosuppressive drug
- • Concurrent use of the following medications or treatments:
- Systemic therapy with psoralens, immunotherapy, or retinoids.
- Cytotoxic chemotherapy for any reason (including methotrexate for arthritis)
- Topical or systemic immunosuppressive therapy
- Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should notify her study physician immediately.
- Uncontrolled concurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion might preclude study participation.
Exclusion
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04091022
Start Date
January 18 2021
End Date
December 11 2025
Last Update
December 17 2025
Active Locations (2)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
UAB Dermatology
Birmingham, Alabama, United States, 35233