Sulforaphane for the Prevention of Melanoma in Patients With Multiple Atypical Nevi and a Prior History of Melanoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
ECOG-ACRIN Cancer Research Group
Study ID
NCT07040280
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clinical Stage 0 Cutaneous Melanoma AJCC v8
  • Clinical Stage I Cutaneous Melanoma AJCC v8
  • Clinical Stage II Cutaneous Melanoma AJCC v8
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Cutaneous Dysplastic Nevus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo optional excisional biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Placebo Administration — DRUG
    Given PO
  • Sulforaphane — DRUG
    Given PO

Study Details

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.

Key Dates

First listed
Jun 27, 2025
Start date
Feb 20, 2026
Status verified
May 2026
Primary completion
Mar 1, 2031
Completion
Mar 1, 2033

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm A (sulforaphane)
    Patients receive sulforaphane PO BID for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study.
  • Placebo Comparator: Arm B (placebo)
    Patients receive placebo PO BID for up to 12 months in the absence of unacceptable toxicity. Patients also undergo optional excisional biopsy at baseline, 3 and 12 months and post treatment and blood sample collection throughout study.

Primary Outcome Measure

Change in total area of atypical and common pigmented nevocellular nevi on the posterior trunk [ Time Frame: From baseline to 12 months after randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Site Public Contact
412-647-8073
John M. Kirkwood (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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