Topical Chemoprevention of Skin Cancer Biomarkers

  • STATUS
    Recruiting
  • End date
    Sep 24, 2021
  • participants needed
    24
  • sponsor
    University of Alabama at Birmingham
Updated on 24 January 2021
platelet count
cancer
corticosteroids
tubal ligation
hysterectomy
melanoma skin
skin cancer
NSAID
vitamin
cancer biomarkers

Summary

This research study will test how well one topical medications work to prevent the development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This study is also looking at the optimal dose of a medication in a small number of people. Biomarkers are molecules that are found in the body and inside of cells. Some biomarkers are associated with specific diseases such as skin cancer. In this study, one topical medication will be evaluated; diclofenac. Diclofenac and is approved by the Food and Drug Administration (FDA) for other uses. 24 patients will be enrolled in this study by University of Alabama at Birmingham.

Description

Men and women ( 18 yo)who have been seen as patients in the Dermatology Clinic at the University of Alabama at Birmingham with a history of basal cell or squamous cell carcinoma of the skin and at least 8 actinic keratoses on the upper extremities are potentially eligible for study participation.

We propose to examine one topical medication which is already FDA approved,with a placebo comparator. The purpose of the study is to see if diclofenac applied daily will affect levels of specific biomarkers in the skin that are associated with risk of developing skin cancer. We hope to see these levels decrease with once daily use of this medication. Results from this study will help guide us in a second study where we will look at longer term use of these medications and how they are associated with changes in skin biomarkers that are related to skin cancer. The second longer study will use the dose (once or twice daily topical application of diclofenac and DMFO) that resulted in a decrease in biomarkers, as discovered in this currently proposed study.

Details
Condition Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer
Treatment Placebo, topical DFMO+diclofenac twice daily, topical diclofenac daily
Clinical Study IdentifierNCT02636569
SponsorUniversity of Alabama at Birmingham
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-melanoma Skin Cancer?
Do you have any of these conditions: Do you have Non-melanoma Skin Cancer??
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 o 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 <
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 14 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 topical DFMO + topical diclofenac on the developing fetus are unknown. Therefore all females of childbearing potential 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 6 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 (retin A, 5-FU, imiquimod) in the 6 months prior to
randomization
Laser resurfacing, dermabrasion, cryotherapy, chemical peel and
electrodissection curettage in the 6 months prior to randomization
Nasally inhaled corticosteroids (except mometasone - Nasonex) 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 the principal investigator believes there is little to no risk of recurrence
Solid organ or bone marrow transplant Keloid formation Photosensitivity
disorder Hypersensitivity or adverse reactions to nonsteroidal anti-
inflammatory agents or to DFMO Any disease that predisposes to NMSC An
immunodeficiency disorder or the use of an immunosuppressive drug Any skin
disease that would interfere with interpretation of results
Any family history of Ornithine diaminotransferase deficiency in a first degree relative
Concurrent use of the following medications or treatments Anticoagulants including warfarin and heparin Other NSAIDs (other than aspirin <100 mg/day) on a daily basis Topical chemotherapy, cryotherapy, radiotherapy or any other skin lesion treatment to areas of skin being followed in this study Systemic therapy with psoralens, immunotherapy, retinoids, or radiation therapy Cytotoxic chemotherapy for any reason (including methotrexate for arthritis) Laser resurfacing, dermabrasion or chemical peels 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 the study physician immediately
Uncontrolled concurrent illness including ongoing or active infection, 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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