Status:
COMPLETED
Bowman-Birk Inhibitor Concentrate in Healthy Men
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Healthy, no Evidence of Disease
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 healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. T...
Detailed Description
OBJECTIVES: I. Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when administered as a suspension in orange juice in healthy male participants. II. Determine the appropria...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area
- ECOG performance status 0-2
- WBC ≥ 3,000/uL
- Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
- Platelet count normal
- Hemoglobin normal
- Hematocrit normal
- RBC normal
- Creatinine normal
- Bilirubin normal
- ALT and AST normal
- Amylase and lipase normal
- Glucose normal
- Cholesterol normal
- Triglycerides normal
- Non-smoker
- Former smokers are eligible provided they have not smoked within the past 3 months
- Within 15% of ideal body weight based on standard weight tables
- No vegetarians or individuals who normally ingest large amounts of soy products, defined as two or more servings of tofu, soy milk, or other primarily soy-based food per day
- No prior allergy or adverse reaction to soybeans
- No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
- No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis
- No history of heart disease
- EKG normal (normal variants allowed)
- No evidence of psychiatric problems
- No history of excessive alcohol consumption (i.e., an average of \> 2 alcoholic beverages per day)
- No alcohol consumption within the past 3 days
- No history of any medical condition that could influence gastrointestinal uptake of the drug
- No history of chronic medical condition
- No evidence of another life-threatening disease
- More than 12 months since prior chemotherapy
- More than 1 month since prior experimental drugs
- More than 2 weeks since prior and no concurrent regular use (i.e., \> 3 times/week) of nonsteroidal anti-inflammatory drugs (NSAIDs)
- More than 2 weeks since prior and no concurrent multivitamin tablets (or other vitamin supplements) of \> 2 per day
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00679094
Start Date
June 1 2007
End Date
December 1 2009
Last Update
December 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104