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A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Atypical Nevi, Melanoma

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Trial Information

A Pilot Study Evaluation of Sulforaphane in Atypical Nevi--Precursor Lesions: Assessment of STAT1 and STAT3 Risk Markers of Melanoma


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.


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.

- Subject must not be a tobacco user or quit at least 6 months prior to the first
administration of the BSE-SFN as tobacco has been found to interfere with the
measurement of SFN metabolites.

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Adverse events associated with oral sulforaphane

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

John M Kirkwood, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

10-114

NCT ID:

NCT01568996

Start Date:

August 2012

Completion Date:

March 2015

Related Keywords:

  • Atypical Nevi
  • Melanoma
  • Melanoma
  • Nevus
  • Nevus, Pigmented
  • Dysplastic Nevus Syndrome

Name

Location
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania  15232