Status:
COMPLETED
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lip and Oral Cavity Cancer
Oral Leukoplakia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 histolog...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00330382
Start Date
January 1 1999
End Date
May 1 2013
Last Update
December 19 2014
Active Locations (1)
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1
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868