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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20
Given orally
Given orally
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Time frame: Up to 4 weeks
Pharmacokinetics measurements of BBI in the blood and urine
Mean, median and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.
Time frame: 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration
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