Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Drug: Bowman-Birk inhibitor concentrateOther: placebo
- Registration Number
- NCT00287833
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
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Healthy volunteer
-
Male
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Performance status - ECOG 0-2
-
RBC normal
-
WBC ≥ 3,000/mm^3
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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
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No history of pancreatic cancer or pancreatic adenoma
-
Amylase normal
-
Lipase normal
-
Cholesterol normal
-
Triglycerides normal
-
Serum glucose ± 10% of normal
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Within 15% of ideal body weight
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No history of chronic medical condition
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No history of excessive alcohol consumption (i.e., > 2 alcoholic beverages per day on average)
-
No history of amyloidosis
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Non-smoker
- Former smokers are eligible provided they have not smoked within the past 3 months
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No history of medical condition that would influence gastrointestinal uptake of the study drug
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No history of diabetes mellitus
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No allergy or prior adverse reaction to soybeans
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Not a vegetarian
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No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
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No evidence of other life-threatening disease
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No evidence of psychiatric problems
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More than 12 months since prior chemotherapy
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More than 1 month since prior experimental drugs
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More than 3 days since prior consumption of alcoholic beverages
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More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs
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More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of > 2 per day
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No more than 2 multivitamin tablets (or other vitamin supplements) per day during study participation
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No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I (Bowman-Birk inhibitor concentrate) Bowman-Birk inhibitor concentrate 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. Arm II (placebo) placebo 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.
- Primary Outcome Measures
Name Time Method Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD) Up to 4 weeks
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Abramson Cancer Center of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States