Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

• ClinicalTrials.gov Identifier: NCT00287833
• Recruitment Status: Completed
• First Posted: February 7, 2006
• Last Update Posted: May 3, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Other: placebo; Drug: Bowman-Birk inhibitor concentrate	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age
• Study Start Date: January 2006
• Actual Primary Completion Date: April 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Bowman-Birk inhibitor concentrate; Given orally; Other Name: BBIC
Placebo Comparator: 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.	Other: placebo; Given orally; Other Name: PLCB

Outcome Measures

Primary Outcome Measures :

1. Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD) [ Time Frame: Up to 4 weeks ]

Secondary Outcome Measures :

1. Pharmacokinetics measurements of BBI in the blood and urine [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Robert Lustig; Abramson Cancer Center of the University of Pennsylvania

More Information

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00287833
• Other Study ID Numbers: NCI-2011-01479; UPCC-706366; N01-CN-25118; CDR0000429594
• First Posted: February 7, 2006
• Last Update Posted: May 3, 2013
• Last Verified: May 2013