Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

NCT01568996 | Completed Early Phase 1 DMC

• 1 other identifier: 10-114
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Atypical Nevi; Melanoma

Keywords

atypical nevi; melanoma; sulforaphane; broccoli; lesions; STAT1; STAT3

Outcome Measures

Primary Outcomes (3)

• Adverse events associated with oral sulforaphane

  2 years

• Visual changes of atypical nevi: size, border, color.

  2 years

• Cellular changes of the atypical nevi.

  2 years

Secondary Outcomes (2)

• Sulforaphane levels in the blood as a result of the 3 doses.

  2 years

• Effects of sulforaphane on STAT1 and STAT3 expression.

  2 years

Study Arms (3)

Low dose BSE-SFN

EXPERIMENTAL

BSE-SFN will be orally administered at 50 µmol SFN for 28 days.

Drug: broccoli sprout extract - sulforaphane (BSE-SFN)

Mid dose BSE-SFN

EXPERIMENTAL

BSE-SFN will be orally administered at 100 µmol SFN for 28 days.

Drug: broccoli sprout extract - sulforaphane (BSE-SFN)

High dose BSE-SFN

EXPERIMENTAL

BSE-SFN will be orally administered at 200 µmol SFN for 28 days.

Drug: broccoli sprout extract - sulforaphane (BSE-SFN)

Interventions

broccoli sprout extract - sulforaphane (BSE-SFN) DRUG

50 µmol capsules, taken orally, once a day for 28 days

Low dose BSE-SFN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• John Kirkwood: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Dysplastic Nevus Syndrome; Melanoma

Condition Hierarchy (Ancestors)

Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John M Kirkwood, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Vice Chairman for Clinical Research

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)