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

Sponsors and Collaborators:	Chao Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00330382

Purpose

RATIONALE: 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.

PURPOSE: This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia.

Condition	Intervention	Phase
Head and Neck Cancer Precancerous/Nonmalignant Condition	Drug: Bowman-Birk inhibitor concentrate Drug: placebo	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Chemoprevention [ Designated as safety issue: No ]
Clinical and histologic response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effects on intermediate marker endpoint levels [ Designated as safety issue: No ]
Correlation of clinical and histologic response with cellular levels of proteolytic activity, erb-B2 (neu), retinioc acid receptor β, bcl-2, and mutant p53 expression, and serum levels of neu [ Designated as safety issue: No ]
Individual and group side effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	210
Study Start Date:	June 2006

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months	Drug: Bowman-Birk inhibitor concentrate Given orally
Arm II: Placebo Comparator Patients receive oral placebo twice daily for 6 months	Drug: placebo Given orally

Detailed Description:

OBJECTIVES:

Primary

Determine if chemoprevention by the Bowman-Birk inhibitor concentrate (BBIC) can prevent cancer in patients with oral leukoplakia (OL).
Determine the clinical and histologic response rate of OL to BBIC.

Secondary

Measure the effect of BBIC on intermediate marker endpoint levels.
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.
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.

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330382

Locations

United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Recruiting
Orange, California, United States, 92868
Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-UC-STUDY ucstudy@uci.edu
Jonsson Comprehensive Cancer Center at UCLA	Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719
USC/Norris Comprehensive Cancer Center and Hospital	Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami	Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lori J. Wirth, MD 617-632-3090 lori_wirth@dfci.harvard.edu

Sponsors and Collaborators

Chao Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Frank L. Meyskens, MD, FACP

Chao Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000468576, UCIRVINE-UCI-98-34, UCIRVINE-UCI-1998-521
Study First Received:	May 25, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00330382
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

lip and oral cavity cancer
oropharyngeal cancer
oral leukoplakia

Study placed in the following topic categories:

Mouth Diseases
Pathological Conditions, Anatomical
Oral leukoplakia
Leukoplakia, Oral
Precancerous Conditions
Oral cancer

Head and Neck Neoplasms
Leukoplakia
Stomatognathic Diseases
Lip and oral cavity cancer
Mouth Neoplasms
Dental Caries

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009