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Aspirin as an Ultraviolet Protectant for the Prevention of Melanoma

Trial Status: Active

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.

Inclusion Criteria

  • Must have at least 2 nevi (each >= 5 mm diameter) not clinically suspicious for melanoma that can be biopsied
  • Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

  • The patient is a minor
  • The patient cannot speak/understand English or Spanish * NOTE: A Spanish consent form and certified interpreter can be made available if needed
  • The patient is pregnant or breastfeeding * NOTE: All female patients who have not had a hysterectomy or are not post-menopausal (for at least 1 year) will have a urine pregnancy test
  • The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable
  • The patient has history of allergic reaction to ASA
  • The patient has history of severe asthma
  • The patient has been taking ASA or any non-steroidal anti-inflammatory drug (NSAID) in the past 2 weeks
  • The patient has been taking a blood thinner in the past 2 weeks
  • The patient has history of bleeding disorder
  • The patient has history of peptic ulcer disease
  • The patient has had recent intense UV exposure in the past month

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Douglas Grossman
Phone: 801-581-4682

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.

Trial Phase Phase II

Trial Type Prevention

Lead Organization
Huntsman Cancer Institute / University of Utah

Principal Investigator
Douglas Grossman

  • Primary ID HCI94424
  • Secondary IDs NCI-2019-05618
  • Clinicaltrials.gov ID NCT04066725