Sulforaphane to help prevent new melanomas in people with many atypical moles and a history of melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the preventive potential of oral sulforaphane, taken as Avmacol Extra Strength tablets for 12 months, in adults with at least three atypical nevi and a prior early-stage melanoma. Participants are randomized to sulforaphane or placebo and monitored for changes in the size and number of nevi on the back, using Derma-AI digital imaging. Primary and secondary outcomes focus on the total area and number of nevi with changes after 12 months, analyzed per-protocol and by intent-to-treat. Safety and tolerability are assessed throughout the treatment period. Exploratory aims include effects on inflammation and immune markers.

Why it matters

Who can join: the full rules

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

Where it's running

• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: John M Kirkwood — ECOG-ACRIN Cancer Research Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.