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

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ClinicalTrials.gov Identifier: NCT00330382
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Lip and Oral Cavity Cancer
Oral Leukoplakia
Oropharyngeal Cancer
Tongue Cancer
Interventions: Drug: Bowman-Birk inhibitor concentrate
Other: placebo
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 513 people were screened for participation across all 8 performance sites, of which 188 (37%) were ineligible and 325 were consented.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 325 consented, 157 (48%) completed the run-in period but 25 declined to continue, resulting in 132 randomized patients.

Reporting Groups
  Description
Arm I (Bowman-Birk Inhibitor Concentrate)

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I (Bowman-Birk Inhibitor Concentrate)   Arm II (Placebo)
STARTED   67   65 
COMPLETED   43   48 
NOT COMPLETED   24   17 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Bowman-Birk Inhibitor Concentrate)

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm I (Bowman-Birk Inhibitor Concentrate)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   65   132 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.25  (13.63)   60.64  (12.01)   59.42  (12.87) 
Gender 
[Units: Participants]
     
Female   26   25   51 
Male   41   40   81 


  Outcome Measures

1.  Primary:   Relative Percent Change in Total Lesion Area After 6 Months on Study   [ Time Frame: 6 months ]

2.  Primary:   Number of Participants by Category of Clinical Response at 6 Months   [ Time Frame: 6 months ]

3.  Secondary:   The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen   [ Time Frame: Baselie to 6 months ]

4.  Secondary:   Clinical Impression From Photographs   [ Time Frame: Baseline to 6 months ]

5.  Secondary:   Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)   [ Time Frame: Baseline to 6 months ]

6.  Secondary:   Relative Percent Change in Serum Neu Protein (ng/ml)   [ Time Frame: Baseline to 6 months ]

7.  Secondary:   Relative Percent Change in Protease Activity (Delta RFU/Min/µg)   [ Time Frame: Baseline to 6 months ]

8.  Secondary:   Number of Participants Report at Least 1 Adverse Event During the Study   [ Time Frame: Randomized date to Off-study date, up to 21 months ]

9.  Secondary:   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 ]


  Serious Adverse Events

Time Frame The adverse-event reports were dated on or after randomization, up to 21 months.
Additional Description The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.

Reporting Groups
  Description
Arm I (Bowman-Birk Inhibitor Concentrate)

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies


Serious Adverse Events
    Arm I (Bowman-Birk Inhibitor Concentrate)   Arm II (Placebo)
Total, Serious Adverse Events     
# participants affected / at risk   5/67 (7.46%)   0/65 (0.00%) 
Cardiac disorders     
HEART PROBLEMS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Gastrointestinal disorders     
EPIGASTRIC PAIN     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
General disorders     
COLD     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Infections and infestations     
FINGER INFECTION - LEFT RING     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
C/O "LUMP" TO RT. LOWER GUM     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Surgical and medical procedures     
ADMISSION FOR ORAL SURGERY ON FLOOR MOUTH     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
* Events were collected by non-systematic assessment




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Frank Meyskens, Jr.
Organization: University of California, Irvine
phone: 714-456-6310
e-mail: flmeyske@uci.edu


Publications of Results:
Other Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00330382     History of Changes
Other Study ID Numbers: NCI-2009-00888
98-34
U01CA072294 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2006
First Posted: May 26, 2006
Results First Submitted: October 3, 2014
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014