Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: Bowman-Birk inhibitor concentrate; Other: placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT00287833

CDR0000429594

NCI-2011-01479

N01-CN-25118

UPCC-706366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Arm I (Bowman-Birk inhibitor concentrate)

Experimental group

Description:

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.

Treatment:

Drug: Bowman-Birk inhibitor concentrate

Arm II (placebo)

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo