Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

PRIMARY OBJECTIVES:

I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.

II. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of this drug in these participants.

OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.

Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.

After completion of study treatment, participants are followed periodically for 4 weeks.

Inclusion criteria

• Healthy volunteer
• Male
• Performance status - ECOG 0-2
• RBC normal
• WBC ≥ 3,000/mm^3
• Platelet count normal
• Hemoglobin normal
• Hematocrit normal
• ALT and AST normal
• Bilirubin normal
• Creatinine normal
• No history of heart disease
• EKG normal
• No history of pancreatitis or obstruction of pancreatic ducts
• No history of pancreatic cancer or pancreatic adenoma
• Amylase normal
• Lipase normal
• Cholesterol normal
• Triglycerides normal
• Serum glucose ± 10% of normal
• Within 15% of ideal body weight
• No history of chronic medical condition
• No history of excessive alcohol consumption (i.e., > 2 alcoholic beverages per day on average)
• No history of amyloidosis
• Non-smoker

• Former smokers are eligible provided they have not smoked within the past 3 months
• No history of medical condition that would influence gastrointestinal uptake of the study drug
• No history of diabetes mellitus
• No allergy or prior adverse reaction to soybeans
• Not a vegetarian
• No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
• No evidence of other life-threatening disease
• No evidence of psychiatric problems
• More than 12 months since prior chemotherapy
• More than 1 month since prior experimental drugs
• More than 3 days since prior consumption of alcoholic beverages
• More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs
• More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of > 2 per day
• No more than 2 multivitamin tablets (or other vitamin supplements) per day during study participation
• No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day