A Phase II Double-Blind Trial of Sulforaphane for Therapeutic Prevention of Melanoma in Patients With Multiple Atypical Nevi and a Prior History of Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in total area of atypical and common pigmented nevocellular nevi on the posterior trunk
研究概览
简要总结
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.
详细描述
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 significant changes in area 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 (Intent-to-Treat [ITT] analysis).
II. To determine the effects of 12 months of sulforaphane treatment versus vs placebo on the total area and features of atypical nevi at 12 months, assessed as above in all randomized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Biopsy Procedure (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Biopsy Procedure (Procedure)
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Placebo Administration (Drug)
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.
干预措施: Sulforaphane (Drug)
结局指标
主要结局
Change in total area of atypical and common pigmented nevocellular nevi on the posterior trunk
时间窗: From baseline to 12 months after randomization
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.
Changes in the total area of nevi after 12 months of treatment from the baseline between sulforaphane and placebo arms
时间窗: 12 months of treatment
The change in the total area of atypical and common pigmented nevocellular nevi measured at baseline and after 12 months of treatment, will be assessed in each patient who completed the full 12 months of treatment (with compliance assessed by dosing logs). The difference in the change of total area of nevi between the two arms will be compared using the Wilcoxon rank sum test.
次要结局
- 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)
- Change in number of atypical nevi at baseline and after the last treatment be assessed via automated image analysis(After 12 months of treatment)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Over 12 months)