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

NCT07040280 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: EA6232NCI-2024-02120ECOG-ACRIN-EA6232UG1CA189828
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in total area of atypical and common pigmented nevocellular nevi on the posterior trunk

  Changes in the total area of nevi compared between the arms will be assessed by Derma-AI digital photographic imaging and analysis using image analysis software. The difference in the change of total area of nevi between the two arms will be compared using the Wilcoxon rank sum test.

  From baseline to 12 months after randomization

Secondary Outcomes (2)

• Number of changed atypical nevi on the posterior trunk

  At baseline and 12 months after randomization

• Incidence of adverse events (AEs)

  Up to 12 months

Other Outcomes (3)

• Circulating serum cytokine and chemokine levels

  At baseline and at 3 and 12 months

• Immune cell infiltration

  At baseline and at 3 and 12 months

• Dermoscopic features of the atypical nevi

  Up to 12 months

Study Arms (2)

Arm A (sulforaphane)

EXPERIMENTAL

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.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Sulforaphane

Arm B (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Placebo Administration

Interventions

Biopsy Procedure PROCEDURE

Undergo optional excisional biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Arm A (sulforaphane); Arm B (placebo)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm A (sulforaphane); Arm B (placebo)

Placebo Administration DRUG

Given PO

Arm B (placebo)

Sulforaphane DRUG

Given PO

Also known as: (+/-)-Sulforaphane, 1-isothiocyanato-4-methylsulfinyl-butane, Sulfaforaphane, Sulforafan, Sulphoraphane

Arm A (sulforaphane)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-stage melanoma, defined as either melanoma in situ, localized resected stage I-II node negative melanoma, or resected node negative stage III melanoma who in the assessment of their physician have a low risk of relapse of their prior melanoma within one year of randomization
• Patient must not be currently on targeted or checkpoint immunotherapy or treated within 365 days prior to randomization
• Patient must be ≥ 18 years of age
• Patient must not be pregnant. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 30 days after the last dose of protocol treatment
• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients with a prior or concurrent malignancy (other than the melanoma for which they are on this study), whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen, are eligible for this trial
• Patient must not have a known allergy to cruciferous vegetables

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Interventions

Biopsy; Specimen Handling; sulforaphane

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John M Kirkwood

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 27, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2033
• Last Updated: September 15, 2026

Record last verified: 2026-05

Locations

US (1)