Clinical trial NCT00287833: Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-02-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Pharmacokinetics measurements of BBI in the blood and urine
timeFrame: 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Robert Lustig
role: PRINCIPAL_INVESTIGATOR
References: