Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    144
  • sponsor
    University of Alabama at Birmingham
Updated on 12 May 2021

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 cancer/ keratinocytic cancers.

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 otherwise general good health, will be given topical diclofenac and topical DFMO. They will be compared to individuals, aged 18 years or older, who have extensive actinic damage, but are in otherwise general good health, will be given placebo. All participants must be at increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses, and the presence, at baseline, of at least eight actinic keratoses on the face, neck, scalp and arms. Subjects will be randomized to:

  1. topical diclofenac twice daily and topical DFMO daily
  2. placebo for the topical diclofenac BID and placebo for the topical DFMO daily

Details
Condition Non-melanoma Skin Cancer
Treatment Solaraze and Vaniqa
Clinical Study IdentifierNCT04091022
SponsorUniversity of Alabama at Birmingham
Last Modified on12 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Previous treatment for basal or squamous cell skin cancer stage 0-2 and current evidence of actinic keratosis on the upper extremities (upper arms, forearms and hands), neck, face or scalp
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
Greater than 4 weeks from
Prior major surgery for any indication
Prior chemotherapy, hormonal therapy or radiation therapy for cancer
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 areas of actinic damage 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. For routine analgesia, subjects may take acetaminophen as necessary
Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 31 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 serum pregnancy test within 14 days 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

Within 3 months prior to randomization
Use of oral or intravenous corticosteroids for more than 2 consecutive weeks
Use of inhaled corticosteroids for more than 4 consecutive weeks
Any of the following in the 4 weeks (or as indicated) 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 (including tamoxifen) Note: treatment with finasteride/dutasteride for BPH does not render a participant ineligible
Radiation therapy
Topical medications for the treatment of actinic keratosis or skin cancer (etretinate, 5-FU, imiquimod, ingenol) in the 6 months prior to randomization
Laser resurfacing, dermabrasion, cryotherapy, chemical peel and electrodissection curettage in the 6 months prior to randomization
Aspirin (>100 mg/day) - Note: cardioprotective doses (< 100mg/day) are acceptable
NSAIDs (other than aspirin < 100mg/day) or COX-2 inhibitors > 3 times/week for more than a two week period
Topical steroids
Any personal history of
Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more 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
Any family history of
Ornithine diaminotransferase deficiency in a first degree relative
Concurrent use of the following medications or treatments
Systemic therapy with psoralens, immunotherapy, retinoids, or radiation therapy
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
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