Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet.

Healthy, no Evidence of Disease

Bowman-Birk inhibitor concentrate

placebo

pharmacological study

laboratory biomarker analysis

Abramson Cancer Center of The University of Pennsylvania

Bowman-Birk Inhibitor Concentrate in Healthy Men

Phase I Single Dose Safety and Pharmacokinetic Study of a New Formulation of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age

Presented in a form of time course of serum BBI concentration after BBIC ingestion by the study subjects and peak concentration (Cmax), time to reach peak concentration (Tmax), area under the curve (AUC), and elimination rate constant (kel) and serum half-lives (t1/2) will be calculated for each subject. Mean, median, and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.

National Cancer Institute (NCI)

Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months

Patients receive oral placebo twice daily for 6 months

Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies

Arm I (Bowman-Birk Inhibitor Concentrate)

Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Total

Sex: Female, Male

Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.

Relative Percent Change in Total Lesion Area After 6 Months on Study

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.

The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen

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.

Number of Participants by Category of Clinical Response at 6 Months

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.

Clinical Impression From Photographs

100% x (Posttreatment value - pretreatment value)/(pretreatment value)

Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)

Relative Percent Change in Serum Neu Protein (ng/ml)

Relative Percent Change in Protease Activity (Delta RFU/Min/µg)

The onset of adverse event is between the randomizaiton date and off-study date

Number of Participants Report at Least 1 Adverse Event During the Study

Patients receive oral Bowman-Birk inhibitor concentrate or Placebo twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally Placebo: Given orally laboratory biomarker analysis: Correlative studies

Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups

Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months

Overall Study

Dr. Frank Meyskens, Jr.

Lip and Oral Cavity Cancer

Oral Leukoplakia

Oropharyngeal Cancer

Tongue Cancer

University of California Medical Center At Irvine-Orange Campus

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

Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial

Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.

Unspecified Adult Solid Tumor, Protocol Specific

Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age

Mean, median and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.

bowman birk inhibitor/xərçəng xəstəliyi

Bowman-Birk Inhibitor Concentrate in Healthy Men

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

Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

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