Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

Completed · Phase 1 · Has a placebo group

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00287833

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2006-01-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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