NCT00330382|CompletedPhase 2Results
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial
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Sponsor study identifier
Secondary identifiers
NIH
interventional
325
1 country
1
Study Start
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
May 2013
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
May 25, 2006
Actual (reported)May 26, 2006
Actual (reported)July 2010
Actual (reported)May 2013
Actual (reported)December 19, 2014
Actual (reported)Relative Percent Change in Total Lesion Area After 6 Months on Study
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
6 months
Number of Participants by Category of Clinical Response at 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.
6 months
The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen
Baselie to 6 months
Clinical Impression From Photographs
Baseline to 6 months
Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)
Baseline to 6 months
Relative Percent Change in Serum Neu Protein (ng/ml)
Baseline to 6 months
Relative Percent Change in Protease Activity (Delta RFU/Min/µg)
Baseline to 6 months
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Patients receive oral placebo twice daily for 6 months
Given orally
Given orally
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868, United States
Meyskens FL. Development of Bowman-Birk inhibitor for chemoprevention of oral head and neck cancer. Ann N Y Acad Sci. 2001 Dec;952:116-23. doi: 10.1111/j.1749-6632.2001.tb02732.x.
Meyskens FL Jr. Development of difluoromethyl-ornithine and Bowman-Birk inhibitor as chemopreventive agents by assessment of relevant biomarker modulation: some lessons learned. IARC Sci Publ. 2001;154:49-55.
Armstrong WB, Taylor TH, Kennedy AR, Melrose RJ, Messadi DV, Gu M, Le AD, Perloff M, Civantos F, Goodwin WJ, Wirth LJ, Kerr AR, Meyskens FL Jr. Bowman birk inhibitor concentrate and oral leukoplakia: a randomized phase IIb trial. Cancer Prev Res (Phila). 2013 May;6(5):410-8. doi: 10.1158/1940-6207.CAPR-13-0004.
Frank Meyskens
University of California Medical Center At Irvine-Orange Campus
325 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2006
First Posted
May 26, 2006
Study Start
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
Correlative studies
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Armstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007.
Primary Completion
July 2010
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
December 19, 2014
Results First Posted
December 19, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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