Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Relative Percent Change in Total Lesion Area After 6 Months on Study
研究概览
简要总结
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
详细描述
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 histologic response rate of OL to BBIC.
SECONDARY OBJECTIVES:
I. Measure the effect of BBIC on intermediate marker endpoint levels. II. Correlate the clinical and histologic responses of OL with cellular levels of proteolytic activity, erb-B2 (neu), retinioc acid receptor β, bcl-2, and mutant p53 expression, and serum levels of neu.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm I (Bowman-Birk inhibitor concentrate)
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
干预措施: Bowman-Birk inhibitor concentrate (Drug)
Arm I (Bowman-Birk inhibitor concentrate)
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Patients receive oral placebo twice daily for 6 months
干预措施: placebo (Other)
Arm II (placebo)
Patients receive oral placebo twice daily for 6 months
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Relative Percent Change in Total Lesion Area After 6 Months on Study
时间窗: 6 months
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
Number of Participants by Category of Clinical Response at 6 Months
时间窗: 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.
次要结局
- Relative Percent Change in Serum Neu Protein (ng/ml)(Baseline to 6 months)
- Relative Percent Change in Protease Activity (Delta RFU/Min/µg)(Baseline to 6 months)
- Number of Participants Report at Least 1 Adverse Event During the Study(Randomized date to Off-study date, up to 21 months)
- The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen(Baselie to 6 months)
- Clinical Impression From Photographs(Baseline to 6 months)
- Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)(Baseline to 6 months)
- 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)