) The long term objective of this application is to determine whether Bowman-Birk inhibitor (BBI) in Concentrate (C), a protease inhibitor extracted from soybeans, can cause regression of oral leukoplakia (OL) and whether certain candidate intermediate marker endpoints can predict response by serving as a surrogate for oral leukoplakia. The ultimate goal of this research is to prevent human cancer.
The specific aims are: (1) To conduct a short-term (one-month) phase IIa cancer control chemoprevention trial of BBIC in patients with OL. The purposes of this trial are: a. To determine the effects of BBIC on the oral cavity. b. To measure the response of IME to BBIC. c. To determine the dose of BBIC at which the IME are not further lowered. (2) To conduct a placebo-controlled and randomized long-term phase IIb cancer control chemoprevention trial of BBIC inpatients with OL. Using the dose of BBIC determined in the IIa trial the essential features include: a. To determine the clinical and histologic response rate of OL to BBIC. b. To serially measure the effect of BBIC on IME levels. c. To correlate the clinical and histologic responses of OL to the effect on protease activity levels and levels of c-erb-B and c-fos expression. d. To determine the individual and group side-effects to BBIC

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA072294-04
Application #
6164224
Study Section
Special Emphasis Panel (SRC (P1))
Program Officer
Perloff, Marjorie
Project Start
1997-03-14
Project End
2003-02-28
Budget Start
2000-03-01
Budget End
2001-02-28
Support Year
4
Fiscal Year
2000
Total Cost
$446,886
Indirect Cost
Name
University of California Irvine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
161202122
City
Irvine
State
CA
Country
United States
Zip Code
92697
Armstrong, William B; Taylor, Thomas H; Kennedy, Ann R et al. (2013) Bowman birk inhibitor concentrate and oral leukoplakia: a randomized phase IIb trial. Cancer Prev Res (Phila) 6:410-8
Taylor, Thomas H; Armstrong, William B; Meyskens, Frank L (2010) The effectiveness of chemoprevention agents is underestimated when lesion sizes are rounded. Cancer Prev Res (Phila) 3:136-9
Messadi, Diana V; Wilder-Smith, Petra; Wolinsky, Lawrence (2009) Improving oral cancer survival: the role of dental providers. J Calif Dent Assoc 37:789-98
Goding, Colin; Meyskens Jr, Frank L (2006) Microphthalmic-associated transcription factor integrates melanocyte biology and melanoma progression. Clin Cancer Res 12:1069-73
Meyskens, F L (2001) Development of Bowman-Birk inhibitor for chemoprevention of oral head and neck cancer. Ann N Y Acad Sci 952:116-23
Wan, X S; Meyskens Jr, F L; Armstrong, W B et al. (1999) Relationship between protease activity and neu oncogene expression in patients with oral leukoplakia treated with the Bowman Birk Inhibitor. Cancer Epidemiol Biomarkers Prev 8:601-8