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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
Enrollment 325
Recruitment Details 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 Of 325 consented, 157 (48%) completed the run-in period but 25 declined to continue, resulting in 132 randomized patients.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 67 65
Completed 43 48
Not Completed 24 17
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo) Total
Hide Arm/Group Description

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 67 65 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 65 participants 132 participants
58.25  (13.63) 60.64  (12.01) 59.42  (12.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 65 participants 132 participants
Female
26
  38.8%
25
  38.5%
51
  38.6%
Male
41
  61.2%
40
  61.5%
81
  61.4%
1.Primary Outcome
Title Relative Percent Change in Total Lesion Area After 6 Months on Study
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 43 46
Mean (Standard Deviation)
Unit of Measure: percentage change
-20.6  (52.4) -17.1  (66.4)
2.Primary Outcome
Title Number of Participants by Category of Clinical Response at 6 Months
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 43 46
Measure Type: Number
Unit of Measure: participants
Complete response (CR) 2 2
Partial response (PR) 10 12
Stable disease 27 26
Disease progression 4 6
3.Secondary Outcome
Title The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 41 47
Mean (Standard Deviation)
Unit of Measure: score
1.2  (23.7) 3.6  (15.4)
4.Secondary Outcome
Title Clinical Impression From Photographs
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 45 46
Mean (Standard Deviation)
Unit of Measure: score
4.0  (1.0) 3.6  (0.9)
5.Secondary Outcome
Title Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)
Hide Description 100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Time Frame Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 21 24
Median (95% Confidence Interval)
Unit of Measure: percentage change
-10.1
(-52.3 to 24.6)
-4.2
(-33.6 to 36.7)
6.Secondary Outcome
Title Relative Percent Change in Serum Neu Protein (ng/ml)
Hide Description 100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Time Frame Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 22
Median (95% Confidence Interval)
Unit of Measure: percentage change
-3.9
(-13.5 to 8.1)
-8.1
(-15.3 to 6.6)
7.Secondary Outcome
Title Relative Percent Change in Protease Activity (Delta RFU/Min/µg)
Hide Description 100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Time Frame Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants who have complete data are analyzed in this outcome measure.
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 21 24
Median (95% Confidence Interval)
Unit of Measure: percentage change
15.7
(-23.8 to 74.9)
17.2
(-10.3 to 30.9)
8.Secondary Outcome
Title Number of Participants Report at Least 1 Adverse Event During the Study
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description:

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 67 65
Measure Type: Number
Unit of Measure: participants
Yes: report at least 1 AE 33 25
No: no AE reported 34 40
9.Secondary Outcome
Title Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months
Hide Description [Not Specified]
Time Frame Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants whose data are available and complete are included in the analysis.
Arm/Group Title Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups
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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

Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: percentage change
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups
Comments Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.45
Comments [Not Specified]
Method Spearman Rank Correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Correlation Coefficient
Estimated Value 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups
Comments Correlation of percent change in protease activity with relative percent change in total lesion area
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.88
Comments [Not Specified]
Method Spearman Rank Correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Correlation Coefficient
Estimated Value 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups
Comments Correlation of percent change in serum Neu with relative percent change in total lesion area
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.66
Comments [Not Specified]
Method Spearman Rank Correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Correlation Coefficient
Estimated Value 0.07
Estimation Comments [Not Specified]
Time Frame The adverse-event reports were dated on or after randomization, up to 21 months.
Adverse Event Reporting Description The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
 
Arm/Group Title Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Hide Arm/Group Description

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

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/67 (7.46%)      0/65 (0.00%)    
Cardiac disorders     
HEART PROBLEMS *  1/67 (1.49%)  1 0/65 (0.00%)  0
Gastrointestinal disorders     
EPIGASTRIC PAIN *  1/67 (1.49%)  1 0/65 (0.00%)  0
General disorders     
COLD *  1/67 (1.49%)  1 0/65 (0.00%)  0
Infections and infestations     
FINGER INFECTION - LEFT RING *  1/67 (1.49%)  1 0/65 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
C/O "LUMP" TO RT. LOWER GUM *  1/67 (1.49%)  1 0/65 (0.00%)  0
Surgical and medical procedures     
ADMISSION FOR ORAL SURGERY ON FLOOR MOUTH *  1/67 (1.49%)  1 0/65 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Bowman-Birk Inhibitor Concentrate) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/67 (44.78%)      25/65 (38.46%)    
Cardiac disorders     
CAD *  1/67 (1.49%)  1 0/65 (0.00%)  0
CARDIAC STENT *  0/67 (0.00%)  0 1/65 (1.54%)  1
CARDIOVASCULAR OTHER - GENERAL *  1/67 (1.49%)  2 0/65 (0.00%)  0
CHEST PAIN *  0/67 (0.00%)  0 2/65 (3.08%)  2
Ear and labyrinth disorders     
EAR INFECTION/IRREGULAR BUMP *  1/67 (1.49%)  1 0/65 (0.00%)  0
Gastrointestinal disorders     
ABD PN AND BLOATING *  0/67 (0.00%)  0 1/65 (1.54%)  1
ABDOMINAL PAIN *  0/67 (0.00%)  0 1/65 (1.54%)  1
BAD BREATH *  1/67 (1.49%)  1 0/65 (0.00%)  0
BLEEDING HEMORRHOIDS *  0/67 (0.00%)  0 1/65 (1.54%)  1
BLOATED *  1/67 (1.49%)  1 0/65 (0.00%)  0
CONSTIPATION *  1/67 (1.49%)  1 0/65 (0.00%)  0
DENTAL IMPLANTS *  1/67 (1.49%)  1 0/65 (0.00%)  0
DIARRHEA *  3/67 (4.48%)  4 1/65 (1.54%)  1
DRY MOUTH *  1/67 (1.49%)  1 0/65 (0.00%)  0
EPIGASTRIC PAIN *  1/67 (1.49%)  1 0/65 (0.00%)  0
EPIGASTRIC PAIN AND NAUSEA *  0/67 (0.00%)  0 1/65 (1.54%)  1
FISSURE FX *  1/67 (1.49%)  1 0/65 (0.00%)  0
GAS-BUT THIS HAS DISAPPEARED AFTER BEING ON POWDER FOR ONE WEEK. *  0/67 (0.00%)  0 1/65 (1.54%)  1
GUM BLEEDING *  0/67 (0.00%)  0 1/65 (1.54%)  2
GUM EROSION (SONIC TOOTHBRUSH) *  0/67 (0.00%)  0 1/65 (1.54%)  1
GUMS FEEL SORE/TENDER *  1/67 (1.49%)  1 0/65 (0.00%)  0
INCREASED SENSITIVITY WITH SPICY FOOD, IE FROM MED TO MILD SALSA *  0/67 (0.00%)  0 1/65 (1.54%)  1
LOOSE STOOLS *  0/67 (0.00%)  0 1/65 (1.54%)  1
NAUSEA *  2/67 (2.99%)  2 0/65 (0.00%)  0
NAUSEA/ABD CRAMPING *  0/67 (0.00%)  0 1/65 (1.54%)  1
SOFT STOOL *  2/67 (2.99%)  2 0/65 (0.00%)  0
STOMACH ACHE *  0/67 (0.00%)  0 1/65 (1.54%)  1
STOMACH DISTRESS WITH SPICY FOODS *  1/67 (1.49%)  1 0/65 (0.00%)  0
STOMACH FLU *  1/67 (1.49%)  1 0/65 (0.00%)  0
STOMACH PAIN *  1/67 (1.49%)  1 1/65 (1.54%)  1
TOOTH EXTRACTION *  1/67 (1.49%)  1 0/65 (0.00%)  0
TOOTH INFECTION *  0/67 (0.00%)  0 1/65 (1.54%)  1
TOOTH PULLED/EAR PAIN/ TOOTH DECAY *  1/67 (1.49%)  1 0/65 (0.00%)  0
UPSET STOMACH *  1/67 (1.49%)  1 1/65 (1.54%)  1
UPSET STOMACH AND GAS *  1/67 (1.49%)  1 0/65 (0.00%)  0
VOMITING - 2X THEN STOPPED *  1/67 (1.49%)  1 0/65 (0.00%)  0
General disorders     
BAD COLD *  0/67 (0.00%)  0 1/65 (1.54%)  1
COLD *  3/67 (4.48%)  3 1/65 (1.54%)  1
FLU/COLD *  0/67 (0.00%)  0 1/65 (1.54%)  1
ORAL SORENESS *  2/67 (2.99%)  3 0/65 (0.00%)  0
TIRED. IN RETROSPECT FELT TIRED DUE TO WORK. *  1/67 (1.49%)  1 0/65 (0.00%)  0
Infections and infestations     
COLD SORES *  1/67 (1.49%)  1 0/65 (0.00%)  0
YEAST INFECTION *  1/67 (1.49%)  1 0/65 (0.00%)  0
Injury, poisoning and procedural complications     
CUT HAND WHILE PLAYING SOCCER AND NEEDED STITCHES *  0/67 (0.00%)  0 1/65 (1.54%)  1
FALL, COMPRESSION OF T11-L1 VERTEBRAL BODY *  1/67 (1.49%)  1 0/65 (0.00%)  0
PT FELL. LEFT EYEBROW AREA BRUISED *  1/67 (1.49%)  1 0/65 (0.00%)  0
Metabolism and nutrition disorders     
WEIGHT LOSS 10LB DUE TO PAIN *  0/67 (0.00%)  0 1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders     
BACK PAIN *  0/67 (0.00%)  0 1/65 (1.54%)  1
CHIP FX ON RIGHT BIG TOE *  1/67 (1.49%)  1 0/65 (0.00%)  0
INCREASED TONGUE PAIN *  1/67 (1.49%)  1 0/65 (0.00%)  0
LT. FOOT RUPTURED TENDON *  0/67 (0.00%)  0 1/65 (1.54%)  1
LT. FOOT THROMBUS *  0/67 (0.00%)  0 1/65 (1.54%)  1
LT. FOOT THROMBUS CONTINUES *  0/67 (0.00%)  0 1/65 (1.54%)  3
RT HAND LITTLE FINGER BROKEN *  0/67 (0.00%)  0 1/65 (1.54%)  1
SCIATIC LEG PAIN *  0/67 (0.00%)  0 1/65 (1.54%)  1
SCIATICA *  0/67 (0.00%)  0 1/65 (1.54%)  1
SORE - TONGUE *  0/67 (0.00%)  0 1/65 (1.54%)  1
SORE TONGUE BOTH SIDES *  0/67 (0.00%)  0 1/65 (1.54%)  1
TOUNGE PAIN CONTINUES *  0/67 (0.00%)  0 1/65 (1.54%)  1
TOUNGE SORENESS *  0/67 (0.00%)  0 1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
MASS 2-3 CM ON CT OF ABDOMEN *  1/67 (1.49%)  1 0/65 (0.00%)  0
NEW SPOTS IN THROAT *  0/67 (0.00%)  0 1/65 (1.54%)  1
Nervous system disorders     
COMPLAINED OF TASTE *  0/67 (0.00%)  0 1/65 (1.54%)  1
DIDN'T LIKE TASTE AFTER RUN IN AND THEN RANDOMIZED, STATED THAT HE "DIDN'T FEEL IT WAS WORKING". *  0/67 (0.00%)  0 1/65 (1.54%)  1
HANDS NUMB *  0/67 (0.00%)  0 1/65 (1.54%)  1
HEADACHE *  1/67 (1.49%)  1 0/65 (0.00%)  0
HEADACHES *  1/67 (1.49%)  1 0/65 (0.00%)  0
TASTED LIKE YEAST *  0/67 (0.00%)  0 1/65 (1.54%)  1
TASTES BAD *  1/67 (1.49%)  1 0/65 (0.00%)  0
TONGUE NUMBNESS COMES AND GOES *  1/67 (1.49%)  1 0/65 (0.00%)  0
TONGUE NUMBNESS, TINGLING AND DRY MOUTH *  1/67 (1.49%)  1 0/65 (0.00%)  0
Psychiatric disorders     
DECREASED SEXUAL APPETITE *  0/67 (0.00%)  0 1/65 (1.54%)  1
LOWER LEFT JAW LESION FEELS ODD/STRETCHY *  0/67 (0.00%)  0 1/65 (1.54%)  1
TIRED AND DIDN'T FEEL LIKE TAKING *  1/67 (1.49%)  1 0/65 (0.00%)  0
Renal and urinary disorders     
KIDNEY STONES *  1/67 (1.49%)  2 0/65 (0.00%)  0
URINARY FREQUENCY *  1/67 (1.49%)  1 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
BRONCHITIS *  1/67 (1.49%)  1 0/65 (0.00%)  0
BRONCHITIS/FLU *  1/67 (1.49%)  1 0/65 (0.00%)  0
FLU X 1 *  1/67 (1.49%)  1 0/65 (0.00%)  0
FLU X 2 *  1/67 (1.49%)  1 0/65 (0.00%)  0
FLU X 6 D *  0/67 (0.00%)  0 1/65 (1.54%)  1
HEAD COLD *  1/67 (1.49%)  1 0/65 (0.00%)  0
PNEUMONIA *  0/67 (0.00%)  0 1/65 (1.54%)  1
SINUS INFECTION, TOOK ZITHROMAX *  1/67 (1.49%)  1 0/65 (0.00%)  0
SORE THROAT *  1/67 (1.49%)  1 1/65 (1.54%)  1
THROAT DRY AND CHAULKY *  0/67 (0.00%)  0 1/65 (1.54%)  1
UPPER RESPIRATORY INFECTION AND SORE THROAT *  0/67 (0.00%)  0 1/65 (1.54%)  1
Skin and subcutaneous tissue disorders     
BAD CANKER LOWER LIP *  1/67 (1.49%)  1 0/65 (0.00%)  0
CANKER SORES *  0/67 (0.00%)  0 1/65 (1.54%)  1
CELLULITIS *  0/67 (0.00%)  0 1/65 (1.54%)  1
DRY LIPS *  1/67 (1.49%)  1 0/65 (0.00%)  0
HIVES *  1/67 (1.49%)  1 0/65 (0.00%)  0
INCREASED HAIR LOSS *  0/67 (0.00%)  0 1/65 (1.54%)  1
ITCHY FOREARM, POSSIBLE BUG BITE REACTION *  1/67 (1.49%)  1 0/65 (0.00%)  0
MOUTH SORES *  0/67 (0.00%)  0 1/65 (1.54%)  2
POISON OAK *  0/67 (0.00%)  0 1/65 (1.54%)  1
RASH *  2/67 (2.99%)  2 0/65 (0.00%)  0
REDNESS OUTER ASPECT LIPS *  0/67 (0.00%)  0 1/65 (1.54%)  1
ROOF OF MOUTH MORE SENSITIVE *  1/67 (1.49%)  1 0/65 (0.00%)  0
SHINGLES *  1/67 (1.49%)  1 0/65 (0.00%)  0
SORE MOUTH *  0/67 (0.00%)  0 1/65 (1.54%)  1
SORE MOUTH - CORNERS AND GUMS *  0/67 (0.00%)  0 1/65 (1.54%)  1
THINNING HAIR *  0/67 (0.00%)  0 1/65 (1.54%)  1
ULCERATION (SMALL) *  0/67 (0.00%)  0 1/65 (1.54%)  1
ULCERATION X3 *  0/67 (0.00%)  0 1/65 (1.54%)  1
Surgical and medical procedures     
6 CROWNS *  1/67 (1.49%)  1 0/65 (0.00%)  0
FNA AND BIOPSY OF MASS INTRAMUSCULAR LIPOMA *  1/67 (1.49%)  1 0/65 (0.00%)  0
HOSPITALIZAED RIGHT KNEE REPLACEMENT *  0/67 (0.00%)  0 1/65 (1.54%)  1
SURGERY ON FINGER *  0/67 (0.00%)  0 1/65 (1.54%)  1
UNDERGOING ROOT CANAL *  1/67 (1.49%)  1 0/65 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: Dr. Frank Meyskens, Jr.
Organization: University of California, Irvine
Phone: 714-456-6310
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