This early phase I clinical trial studies sulforaphane in treating patients with atypical nevi previously diagnosed with melanoma. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of sulforaphane may keep cancer from forming in melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01568996.
PRIMARY OBJECTIVES:
I. To determine the safety and clinical as well as pathological effects of oral daily broccoli sprout extract derived sulforaphane administered at dosages of 50, 100, and 200 uM for patients with multiple atypical nevi and a history of melanoma.
SECONDARY OBJECTIVES:
I. To document the pharmacokinetics and pharmacodynamics of broccoli sprout extract - sulforaphane (BSE-SFN) and the ability of oral BSE-SFN to modulate the level of signaling molecules in tissue biopsies of atypical nevi and skin in patients with multiple atypical nevi and a history of melanoma.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive 50 uM dose of sulforaphane orally (PO) once daily (QD) on days 1-28.
ARM II: Patients receive 100 uM dose of sulforaphane PO QD on days 1-28.
ARM III: Patients receive 200 uM dose of sulforaphane PO QD on days 1-28.
After completion of study treatment, patients are followed up at 3 and 6 months.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorJohn Munn Kirkwood
