Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: placebo
* Drug: Bowman-Birk inhibitor concentrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (Bowman-Birk inhibitor concentrate)<br>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. | Drug: Bowman-Birk inhibitor concentrate<br>* Given orally<br>* Other names: BBIC;|
| Placebo Comparator: Arm II (placebo)<br>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. | Other: placebo<br>* Given orally<br>* Other names: PLCB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD) |  | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration |