A Phase 2 interventional study of Bowman-Birk inhibitor concentrate and placebo in Lip and Oral Cavity Cancer, Oral Leukoplakia and Oropharyngeal Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-19.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention
Among 24 studies in Mouth Neoplasms by National Cancer Institute (NCI) — 6 open to participants now, 13 under way, 2 of them phase 3. Mouth Neoplasms · National Cancer Institute (NCI).
Among the 24 studies in Mouth Neoplasms by National Cancer Institute (NCI), this one is the 3rd largest by enrollment of the 18 interventional ones that give a count, is one of 3 that started in 1999, is one of 8 in phase 2, and was the 6th registered.
447 studies on the registry are indexed under Mouth Neoplasms; 131 are open to participants now.
Browse Mouth Neoplasms studies →6 of the 24 studies in Mouth Neoplasms by National Cancer Institute (NCI) are open now, in 2 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 97 Mouth Neoplasms studies recruiting now, 58 (60%) set no upper age limit and 23 (24%) stop at 75 or younger; 5 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 11 · Phase 3 4
First in 1996; this study’s year is marked. 3 started in 1999.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 325 is above the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
Median enrollment 49 across the 18 interventional studies, 80 across the 3 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
5 of the studies in Mouth Neoplasms by National Cancer Institute (NCI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00867464National Cancer Institute (NCI)Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls | 2026-12-23 |
| NCT05136196National Cancer Institute (NCI)BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study | 2027-01-01 |
| NCT05172258National Cancer Institute (NCI)Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck | 2027-06-30 |
| NCT05172245National Cancer Institute (NCI)Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer | 2027-07-01 |
| NCT06980038National Cancer Institute (NCI)Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer | 2027-11-24 |
Add all 5 to your calendar (.ics) → With an account.
Among the 24 studies in Mouth Neoplasms by National Cancer Institute (NCI), from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
III. Determine the individual and group side effects of BBIC.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled, study. Prior to randomization, all patients receive oral placebo for 4 weeks. Patients who show good compliance (> 75% packet count) are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires about diet, tobacco, and alcohol usage at baseline and at the completion of study treatment. Blood, urine, and biopsy tissue are collected at baseline and at the completion of study treatment. Oral mucosal cells are collected at baseline, during the run-in phase, at randomization, after completion of study treatment, and at 3 months after completion of study treatment. Samples are examined for protease activity, levels of bcl-2 and erbB-2, mutant p53 oncogene expression and epidermal growth factor receptor, and retinoic acid receptor-β expression.
After completion of study treatment, patients are followed at 3 months.
Inclusion Criteria:
At least 3 months since prior systemic or topical oral steroid preparations
At least 2 years since prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Drug: Bowman-Birk inhibitor concentrate · Other: laboratory biomarker analysis
Patients receive oral placebo twice daily for 6 months
Other: placebo · Other: laboratory biomarker analysis
Given orally
Also known as: BBIC
Given orally
Also known as: PLCB
Correlative studies
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: Baselie to 6 months
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.
Time frame: Baseline to 6 months
Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Time frame: Baseline to 6 months
Relative Percent Change in Serum Neu Protein (ng/ml)
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Time frame: Baseline to 6 months
Relative Percent Change in Protease Activity (Delta RFU/Min/µg)
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Time frame: Baseline to 6 months
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
Time frame: Randomized date to Off-study date, up to 21 months
Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months
Time frame: Baseline to 6 months
A total of 513 people were screened for participation across all 8 performance sites, of which 188 (37%) were ineligible and 325 were consented.
| Milestone | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Started | 67 | 65 |
| Completed | 43 | 48 |
| Not completed | 24 | 17 |
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
| percentage change | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Relative Percent Change in Total Lesion Area After 6 Months on Study | -20.6 ± 52.4 | -17.1 ± 66.4 |
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.
| score | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen | 1.2 ± 23.7 | 3.6 ± 15.4 |
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.
| participants | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Complete response (CR) | 2 | 2 |
| Partial response (PR) | 10 | 12 |
| Stable disease | 27 | 26 |
| Disease progression | 4 | 6 |
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.
| score | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Clinical Impression From Photographs | 4.0 ± 1.0 | 3.6 ± 0.9 |
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
| percentage change | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Relative Percent Change in Buccal-Cell Neu Protein (ng/mg) | -10.1 (-52.3 to 24.6) | -4.2 (-33.6 to 36.7) |
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
| percentage change | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Relative Percent Change in Serum Neu Protein (ng/ml) | -3.9 (-13.5 to 8.1) | -8.1 (-15.3 to 6.6) |
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
| percentage change | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Relative Percent Change in Protease Activity (Delta RFU/Min/µg) | 15.7 (-23.8 to 74.9) | 17.2 (-10.3 to 30.9) |
The onset of adverse event is between the randomizaiton date and off-study date
| participants | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| Yes: report at least 1 AE | 33 | 25 |
| No: no AE reported | 34 | 40 |
| percentage change | Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups |
|---|---|
| Buccal-Cell New | -8.9 (-24.5 to 18.5) |
| Protease Activity | 16.2 (-10.0 to 27.0) |
| Serum Neu (n=41) | -4.1 (-11.3 to 0.7) |
Collected over The adverse-event reports were dated on or after randomization, up to 21 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Bowman-Birk Inhibitor Concentrate) | — | 5/67 (7.5%) | 30/67 (44.8%) |
| Arm II (Placebo) | — | 0/65 (0%) | 25/65 (38.5%) |
| Event | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| ADMISSION FOR ORAL SURGERY ON FLOOR MOUTHSurgical and medical procedures | 1/67 | 0/65 |
| C/O "LUMP" TO RT. LOWER GUMNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/67 | 0/65 |
| COLDGeneral disorders | 1/67 | 0/65 |
| EPIGASTRIC PAINGastrointestinal disorders | 1/67 | 0/65 |
| FINGER INFECTION - LEFT RINGInfections and infestations | 1/67 | 0/65 |
| HEART PROBLEMSCardiac disorders | 1/67 | 0/65 |
| Event | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) |
|---|---|---|
| COLDGeneral disorders | 3/67 | 1/65 |
| DIARRHEAGastrointestinal disorders | 3/67 | 1/65 |
| CHEST PAINCardiac disorders | 0/67 | 2/65 |
| NAUSEAGastrointestinal disorders | 2/67 | 0/65 |
| ORAL SORENESSGeneral disorders | 2/67 | 0/65 |
| RASHSkin and subcutaneous tissue disorders | 2/67 | 0/65 |
| SOFT STOOLGastrointestinal disorders | 2/67 | 0/65 |
| ABD PN AND BLOATINGGastrointestinal disorders | 0/67 | 1/65 |
| ABDOMINAL PAINGastrointestinal disorders | 0/67 | 1/65 |
| BACK PAINMusculoskeletal and connective tissue disorders | 0/67 | 1/65 |
| Age, Continuous(years) | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) | Total |
|---|---|---|---|
| Mean | 58.25 ± 13.63 | 60.64 ± 12.01 | 59.42 ± 12.87 |
| Sex: Female, Male(Participants) | Arm I (Bowman-Birk Inhibitor Concentrate) | Arm II (Placebo) | Total |
|---|---|---|---|
| Female | 26 | 25 | 51 |
| Male | 41 | 40 | 81 |
The record gives a start of Jan 1999, a primary completion of Jul 2010 and a completion of May 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 4 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bowman-Birk Inhibitor Concentrate
National Cancer Institute (NCI) →