Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

NCT ID: NCT00287833

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I (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.

Group Type: EXPERIMENTAL

Bowman-Birk inhibitor concentrate

Intervention Type: DRUG

Given orally

Arm II (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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Interventions

placebo

Given orally

Intervention Type: OTHER

Bowman-Birk inhibitor concentrate

Given orally

Intervention Type: DRUG

Other Intervention Names

PLCB; BBIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Lustig

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC-706366

Identifier Type: -

Identifier Source: secondary_id

N01-CN-25118

Identifier Type: -

Identifier Source: secondary_id

CDR0000429594

Identifier Type: -

Identifier Source: secondary_id

NCI-2011-01479

Identifier Type: -

Identifier Source: org_study_id