Clinical trial NCT01568996: Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
Official title: A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atypical Nevi
Melanoma
Keywords: atypical nevi
melanoma
sulforaphane
broccoli
lesions
STAT1
STAT3
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.

Detailed description: This study is designed as a pilot evaluation of sulforaphane as a candidate natural nutritional chemopreventive agent able to modulate key steps in melanoma progression and the expression of STAT proteins in melanocytic and stromal elements of atypical nevi, which are precursor lesions and risk markers of melanoma. Eighteen individuals in total will receive oral broccoli sprout extract rich in sulforaphane (BSE-SFN) standardized for 3 different concentrations of actual sulforaphane content which will be utilized in our study. Three groups of six patients will be randomly assigned to receive oral BSE-SFN at SFN dosages of 50 µmol, 100 µmol, or 200 µmol daily. Due to the established safety of SFN at all of the proposed dosage levels, there is no plan to complete a lower dosage level prior to escalating to the next higher dosage level; i.e., subjects will be randomized across all of the proposed SFN dosage levels. However, the safety of BSE-SFN administration will continue to be evaluated through laboratory studies (CBC, chemistry) performed before and following 28 days of administration.

Eligibility criteria: Inclusion Criteria:

* Subjects must have at least two atypical nevi of ≥ 4 mm diameter and prior diagnosis of melanoma.
* Subjects must be ≥ age 18.
* Subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day 1.
* Subjects should not have known allergies to cruciferous vegetables.
* Subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days). Participants will be asked to keep a food diary. A list of food and supplements to abstain from is provided in Appendix A. Patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more times.
* Female subjects must not be pregnant or breast feeding within 6 months prior to and during course of study.
* CBC including diff \& platelets - without clinically significant abnormalities
* CMP (Na, K, Cl, CO2, glucose, BUN, creatinine, calcium, total protein, albumin, AST, ALT, ALK phos, total bilirubin) - within 2x ULN

Exclusion Criteria:

N/A

Primary outcomes:
measure: Adverse events associated with oral sulforaphane
timeFrame: 2 years
measure: Visual changes of atypical nevi: size, border, color.
timeFrame: 2 years
measure: Cellular changes of the atypical nevi.
timeFrame: 2 years
Secondary outcomes:
measure: Sulforaphane levels in the blood as a result of the 3 doses.
timeFrame: 2 years
measure: Effects of sulforaphane on STAT1 and STAT3 expression.
timeFrame: 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Kirkwood, MD
role: PRINCIPAL_INVESTIGATOR
References: