This phase II trial studies how well aspirin works in preventing ultraviolet skin sensitivity and mole damage in patients who have moles and potentially other risk factors for melanoma. Aspirin is a commonly used over-the-counter medicine that is a type of non-steroidal anti-inflammatory drug that may affect other molecules in the skin and moles that relate to melanoma development.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04066725.
PRIMARY OBJECTIVES:
I. Perform a randomized placebo-controlled double-blinded intervention trial of oral aspirin (ASA) in human subjects at increased risk for melanoma.
Ia. To assess the capacity of either of two daily doses (81, 325 mg) of chronic ASA administration to reduce skin ultraviolet (UV)-sensitivity (i.e. increase the minimal erythemal dose, or MED).
Ib. To assess the capacity of either of two daily doses (81, 325 mg) of chronic ASA administration to reduce levels of prostaglandin E2 (PGE2) in plasma.
Ic. To assess the capacity of either of two daily doses (81, 325 mg) of chronic ASA administration to reduce levels of prostaglandin E2 (PGE2) in nevi.
Id. If differences between the trial arms are observed, whether an 81 mg or 325 mg daily dose is more efficacious.
SECONDARY OBJECTIVES:
I. Determine if chronic ASA administration is associated with reduction in the oncometabolite 2-hydroxyglutarate (2-HG) and UV-induced damage in skin/nevi.
Ia. Blood and nevus samples from subjects in the trial will be analyzed for 2-HG to assess the effect of ASA.
Ib. Blood and nevus samples from subjects in the trial will be analyzed for sunburn cells to assess the effect of ASA.
Ic. Blood and nevus samples from subjects in the trial will be analyzed for 8-oxoguanine (8-OG) to assess the effect of ASA.
EXPLORATORY OBJECTIVE:
I. Determine in blood and nevi the presence of ASA and the following ASA-related metabolites: salicylate, salicyl acyl glucuronide, salicylurate, and gentisic acid after chronic ingestion of either of two doses of ASA.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive placebo orally (PO) once daily (QD) on days 1-60 in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection followed by surgery to remove moles on days 1 and 8.
ARM II: Patients receive low dose aspirin PO QD on days 1-60 in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection followed by surgery to remove moles on days 1 and 8.
ARM III: Patients receive high dose aspirin PO QD on days 1-60 in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection followed by surgery to remove moles on days 1 and 8.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorDouglas Grossman
