Status:
COMPLETED
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00287833
Start Date
January 1 2006
Last Update
May 3 2013
Active Locations (1)
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1
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104