A Phase I Pre-cystectomy Trial of Broccoli Extract in Patients With Advanced Bladder Cancer
I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200
micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo
definitive bladder resection for bladder cancer.
I. Establish the safety of administration of the broccoli extract on the bladder surgery
II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign
urothelium and bladder cancer tissue.
III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by
measuring angiogenesis, cell proliferation and apoptosis.
IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per
dose per day of broccoli sprout extract in future therapeutic and prevention clinical
Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the
absence of disease progression or unacceptable toxicity. After completion of study
treatment, patients are followed at 4 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria version 3.0
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|