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Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00287833
First received: February 6, 2006
Last updated: May 1, 2013
Last verified: May 2013
  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. 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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Other: placebo
Drug: Bowman-Birk inhibitor concentrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Lustig Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00287833     History of Changes
Other Study ID Numbers: NCI-2011-01479, UPCC-706366, N01-CN-25118, CDR0000429594
Study First Received: February 6, 2006
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014