ECOG-ACRIN Cancer Research Group
This phase II trial tests how well sulforaphane works in preventing melanoma in patients with multiple atypical moles (nevi) and a prior history of melanoma. Patients with a history of melanoma and multiple atypical nevi are at a significantly increased risk of developing additional melanomas than those without atypical nevi. Prevention measures usually include sun protection, monthly skin self-examinations and regular skin examinations from a doctor. Sulforaphane is a naturally-occurring substance found in many cruciferous vegetables, including broccoli, that may prevent melanoma from forming.
PRIMARY OBJECTIVE: I. To evaluate the effects of oral sulforaphane versus (vs) placebo on change in the total area of atypical and common pigmented nevocellular nevi on the posterior trunk at 12 months after randomization as assessed by digital photographic imaging and analysis using Derma-AI image analysis software, specifically assessed in patients treated for the entire 12-month treatment period (per-protocol analysis). SECONDARY OBJECTIVES: I. To evaluate the effects of oral sulforaphane vs placebo on the number of atypical and common pigmented nevocellular nevi with moderate and signif…
Inclusion Criteria: * Patient must have ≥ 3 clinically atypical nevi, assessed within 30 days prior to randomization, that are consistent with the International Agency for Research on Cancer (IARC) definition as follows. * Must have a diameter of ≥ 5mm in one dimension * Must include a macular component in at least one area * Must have at least two of the following features: ill-defined borders, color variegation, uneven contour, and erythema NOTE: Lesions suspicious for incipient melanoma will be removed and are not intended for the study * Patient must have a prior diagnosis of early…
Undergo optional excisional biopsy
Undergo blood sample collection
Given PO
Given PO
Arctuva estimate
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