Recruiting
Phase 2

Sulforaphane

Sponsor:

ECOG-ACRIN Cancer Research Group

Code:

NCT07040280

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+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Placebo Administration

Sulforaphane

Study Details

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 I Cutaneous Melanoma AJCC v8

Clinical Stage II Cutaneous Melanoma AJCC v8

Clinical Stage III Cutaneous Melanoma AJCC v8

Cutaneous Dysplastic Nevus

Study ID

NCT07040280

Start date

Feb 20, 2026

Status verified date

May, 2026

Completion date

Mar 1, 2033

Anticipated

Primary completion date

Mar 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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-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
  • Patients must not use any other sulforaphane-containing dietary supplement during the study period
  • Patient must not be on any current systemic treatment for melanoma

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Biopsy Procedure

Undergo optional excisional biopsy

Biospecimen Collection

Undergo blood sample collection

Placebo Administration

Given PO

Sulforaphane

Given PO

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 ]

Central Contacts and Locations

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

John M. Kirkwood

More Information

Sponsor

ECOG-ACRIN Cancer Research Group

Last update posted

Sep 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by ECOG-ACRIN Cancer Research Group on 2026-09-15.