Phase 2
N=132
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Lip and Oral Cavity Cancer · Oral Leukoplakia · Oropharyngeal Cancer · Tongue Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00330382 ↗Enrolled (actual)
132
Serious AEs
3.8%
Results posted
Dec 2014
Primary outcome: Primary: Relative Percent Change in Total Lesion Area After 6 Months on Study — -20.6; -17.1 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bowman-Birk inhibitor concentrate (Drug); placebo (Other); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Percent Change in Total Lesion Area After 6 Months on Study |
-20.6; -17.1 | — |
| PRIMARY Number of Participants by Category of Clinical Response at 6 Months |
2; 2; 10; 12; 27; 26 | — |
| SECONDARY The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen |
1.2; 3.6 | — |
| SECONDARY Clinical Impression From Photographs |
4.0; 3.6 | — |
| SECONDARY Relative Percent Change in Buccal-Cell Neu Protein (ng/mg) |
-10.1; -4.2 | — |
| SECONDARY Relative Percent Change in Serum Neu Protein (ng/ml) |
-3.9; -8.1 | — |
| SECONDARY Relative Percent Change in Protease Activity (Delta RFU/Min/µg) |
15.7; 17.2 | — |
| SECONDARY Number of Participants Report at Least 1 Adverse Event During the Study |
33; 25; 34; 40 | — |
| SECONDARY Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months |
-8.9; 16.2; -4.1 | >0.45 |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00330382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.