Oropharyngeal Cancer Clinical Trial
Official title:
Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial
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
Status | Completed |
Enrollment | 325 |
Est. completion date | May 2013 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of California Medical Center At Irvine-Orange Campus | Orange | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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). — View Citation
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 — View Citation
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen | The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period. | Baselie to 6 months | No |
Secondary | Clinical Impression From Photographs | A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, "top photo shows a complete response relative to the bottom photo," through, "the same degree of disease is shown by top photo and bottom photo," to "bottom photo shows a complete response relative to the top photo." Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo. | Baseline to 6 months | No |
Secondary | Relative Percent Change in Buccal-Cell Neu Protein (ng/mg) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | Baseline to 6 months | No |
Secondary | Relative Percent Change in Serum Neu Protein (ng/ml) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | Baseline to 6 months | No |
Secondary | Relative Percent Change in Protease Activity (Delta RFU/Min/µg) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | Baseline to 6 months | No |
Secondary | Number of Participants Report at Least 1 Adverse Event During the Study | The onset of adverse event is between the randomizaiton date and off-study date | Randomized date to Off-study date, up to 21 months | Yes |
Secondary | Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months | Baseline to 6 months | No |
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