Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men - Full Text View

Sponsors and Collaborators:	University of Pennsylvania National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00287833

Purpose

RATIONALE: 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.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Dietary Supplement: Bowman-Birk inhibitor concentrate	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety as measured by NCI Common Toxicity Criteria [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.
Determine a safe dose range of this drug in these participants.
Determine a recommended phase II dose of this drug in these participants.

Secondary

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.

PROJECTED ACCRUAL: A total of 20 participants (5 per dose level cohort) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Healthy volunteer

PATIENT CHARACTERISTICS:

Age

18 to 65

Sex

Male

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

RBC normal
WBC ≥ 3,000/mm^3
Platelet count normal
Hemoglobin normal
Hematocrit normal

Hepatic

ALT and AST normal
Bilirubin normal

Renal

Creatinine normal

Cardiovascular

No history of heart disease
EKG normal

Gastrointestinal

No history of pancreatitis or obstruction of pancreatic ducts
No history of pancreatic cancer or pancreatic adenoma

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 12 months since prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287833

Locations

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert A. Lustig, MD

University of Pennsylvania

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000429594, UPCC-706366
Study First Received:	February 6, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00287833 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009