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Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia

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ClinicalTrials.gov Identifier: NCT00330382
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE May 25, 2006
First Posted Date  ICMJE May 26, 2006
Results First Submitted Date  ICMJE October 3, 2014
Results First Posted Date  ICMJE December 19, 2014
Last Update Posted Date December 19, 2014
Study Start Date  ICMJE January 1999
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Relative Percent Change in Total Lesion Area After 6 Months on Study [ Time Frame: 6 months ]
    Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
  • Number of Participants by Category of Clinical Response at 6 Months [ Time Frame: 6 months ]
    Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00330382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen [ Time Frame: Baselie to 6 months ]
    The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period.
  • Clinical Impression From Photographs [ Time Frame: Baseline to 6 months ]
    A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, "top photo shows a complete response relative to the bottom photo," through, "the same degree of disease is shown by top photo and bottom photo," to "bottom photo shows a complete response relative to the top photo." Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo.
  • Relative Percent Change in Buccal-Cell Neu Protein (ng/mg) [ Time Frame: Baseline to 6 months ]
    100% x (Posttreatment value - pretreatment value)/(pretreatment value)
  • Relative Percent Change in Serum Neu Protein (ng/ml) [ Time Frame: Baseline to 6 months ]
    100% x (Posttreatment value - pretreatment value)/(pretreatment value)
  • Relative Percent Change in Protease Activity (Delta RFU/Min/µg) [ Time Frame: Baseline to 6 months ]
    100% x (Posttreatment value - pretreatment value)/(pretreatment value)
  • Number of Participants Report at Least 1 Adverse Event During the Study [ Time Frame: Randomized date to Off-study date, up to 21 months ]
    The onset of adverse event is between the randomizaiton date and off-study date
  • Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months [ Time Frame: Baseline to 6 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Official Title  ICMJE Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial
Brief Summary This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia
Detailed Description

PRIMARY OBJECTIVES:

I. Determine if chemoprevention by the Bowman-Birk inhibitor concentrate (BBIC) can prevent cancer in patients with oral leukoplakia (OL).

II. Determine the clinical and histologic response rate of OL to BBIC.

SECONDARY OBJECTIVES:

I. Measure the effect of BBIC on intermediate marker endpoint levels. II. Correlate the clinical and histologic responses of OL with cellular levels of proteolytic activity, erb-B2 (neu), retinioc acid receptor β, bcl-2, and mutant p53 expression, and serum levels of neu.

III. Determine the individual and group side effects of BBIC.

OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled, study. Prior to randomization, all patients receive oral placebo for 4 weeks. Patients who show good compliance (> 75% packet count) are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires about diet, tobacco, and alcohol usage at baseline and at the completion of study treatment. Blood, urine, and biopsy tissue are collected at baseline and at the completion of study treatment. Oral mucosal cells are collected at baseline, during the run-in phase, at randomization, after completion of study treatment, and at 3 months after completion of study treatment. Samples are examined for protease activity, levels of bcl-2 and erbB-2, mutant p53 oncogene expression and epidermal growth factor receptor, and retinoic acid receptor-β expression.

After completion of study treatment, patients are followed at 3 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Lip and Oral Cavity Cancer
  • Oral Leukoplakia
  • Oropharyngeal Cancer
  • Tongue Cancer
Intervention  ICMJE
  • Drug: Bowman-Birk inhibitor concentrate
    Given orally
    Other Name: BBIC
  • Other: placebo
    Given orally
    Other Name: PLCB
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE
  • Experimental: Arm I (Bowman-Birk inhibitor concentrate)
    Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
    Interventions:
    • Drug: Bowman-Birk inhibitor concentrate
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm II (placebo)
    Patients receive oral placebo twice daily for 6 months
    Interventions:
    • Other: placebo
    • Other: laboratory biomarker analysis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2014)
325
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically and clinically confirmed oral leukoplakia and/or erythroplakia
  • Bidimensionally measurable disease (≥ 100 mm^2 for total area of all lesions) after biopsy
  • No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or previously treated head and neck cancer within the past 2 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings, aspartame, saccharin, or lidocaine
  • At least 6 months since prior Bowman-Birk inhibitor concentrate
  • At least 6 months since prior participation in another randomized clinical trail
  • At least 3 months since prior systemic steroids or topical oral steroid preparations

    • Topical nasal steroid sprays or cutaneous preparations with minimal systemic absorption for nasal or dermatologic disorders allowed
  • More than 6 months since prior beta carotene capsules
  • At least 2 years since prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason

    • Up to 2 multivitamins per day allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330382
Other Study ID Numbers  ICMJE NCI-2009-00888
98-34
U01CA072294 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank Meyskens University of California Medical Center At Irvine-Orange Campus
PRS Account National Cancer Institute (NCI)
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP