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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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