This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate may prevent cancer.

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