Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Brief summary
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
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.
Interventions
Given orally
Given orally
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD) | Up to 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics measurements of BBI in the blood and urine | 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration | 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. |
Countries
United States