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

NCT00330382 | Completed Phase 2 Results

• 3 other identifiers: NCI-2009-0088898-34U01CA072294
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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 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

Conditions

Lip and Oral Cavity Cancer; Oral Leukoplakia; Oropharyngeal Cancer; Tongue Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

Arm I (Bowman-Birk inhibitor concentrate)

EXPERIMENTAL

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

Drug: Bowman-Birk inhibitor concentrate; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 6 months

Other: placebo; Other: laboratory biomarker analysis

Interventions

Bowman-Birk inhibitor concentrate DRUG

Given orally

Also known as: BBIC

Arm I (Bowman-Birk inhibitor concentrate)

placebo OTHER

Given orally

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (Bowman-Birk inhibitor concentrate); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

Related Publications (4)

• 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. doi: 10.1111/j.1749-6632.2001.tb02732.x.

  PMID: 11795430 BACKGROUND

• 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.

  PMID: 11220668 BACKGROUND

• 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). 2013 May;6(5):410-8. doi: 10.1158/1940-6207.CAPR-13-0004.

  PMID: 23639862 RESULT

• 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. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007.

  PMID: 14520092 RESULT

MeSH Terms

Conditions

Mouth Neoplasms; Leukoplakia, Oral; Oropharyngeal Neoplasms; Tongue Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Leukoplakia; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Tongue Diseases

Results Point of Contact

• Title: Dr. Frank Meyskens, Jr.
• Organization: University of California, Irvine

flmeyske@uci.edu

714-456-6310

Study Officials

• Frank Meyskens

  University of California Medical Center At Irvine-Orange Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2006
• First Posted: May 26, 2006
• Study Start: January 1, 1999
• Primary Completion: July 1, 2010
• Study Completion: May 1, 2013
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-02

Locations

US (1)