Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01207687
Recruitment Status : Completed
First Posted : September 23, 2010
Results First Posted : August 17, 2017
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Vestibular Schwannoma
Neurofibromatosis Type 2
Interventions Biological: bevacizumab
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 14
Completed 12
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Treatment (Bevacizumab)
Hide Arm/Group Description People with NF2, not eligible for surgery with progressive vestibular schwannoma
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
2
  14.3%
Between 18 and 65 years
11
  78.6%
>=65 years
1
   7.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
30.5
(14 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
10
  71.4%
Male
4
  28.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
  78.6%
More than one race
0
   0.0%
Unknown or Not Reported
2
  14.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
 100.0%
Karnofsky performance status scale   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 14 participants
80
(70 to 90)
[1]
Measure Description: The Karnofsky performance status (KPS) scale is a provider reported measure of functional status. Decile scores are assigned, ranging from 0 to 100. A lower score (minimum 0) represents greater functional impairment. A higher score (maximum 100) represents less functional impairment. KPS can be used measure changes in a patient's functional status.
word recognition score of target ear   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 14 participants
60.5
(13 to 82)
[1]
Measure Description: The word recognition score (WRS) is the percentage of phonetically-balanced, monosyllabic words that a patient can accurately repeat presented at either most comfortable level or most intelligible level
1.Primary Outcome
Title Proportion of Patients With Hearing Response
Hide Description A hearing response was defined as increased word recognition score above the 95% critical threshold that is maintained across two sequential evaluation time points. The word recognition score (WRS) is the percentage of phonetically-balanced, monosyllabic words that a patient can accurately repeat presented at either most comfortable level or most intelligible level.The proportion of patients with hearing response in the target ear was estimated using a binomial distribution along with 95% confidence intervals.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All people who underwent treatment were analyzed. Two patients stopped treatment early. One due to toxicity at week 25 and one due to need for medical care not permitted while on treatment at week 49.
Arm/Group Title Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants Only
Hide Arm/Group Description:
Patients who met all eligibility criteria underwent baseline evaluation and then received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Hearing evaluation for word recognition score was evaluated every 12 weeks. Hearing response was defined as improvement beyond the 95% CI maintained across 2 timepoints.
All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion with hearing response
0.36
(0.13 to 0.65)
0.50
(0.01 to 0.99)
2.Secondary Outcome
Title Incidence of Serious or Life Threatening Toxicities
Hide Description The number of patients with serious or life threatening toxicities (CTCAE grade 3 or above)
Time Frame Up to 6 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants evaluated for serious or life threatening toxicities
Arm/Group Title Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Hide Arm/Group Description:
All enrolled patients received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
Overall Number of Participants Analyzed 14 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
  14.3%
0
   0.0%
3.Secondary Outcome
Title Radiographic Response
Hide Description The proportion of participants with radiographic response as measured by a >/= 20% reduction in tumor volume from baseline on MRI imaging will be estimated using a binomial distribution.
Time Frame Baseline to 6 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Hide Arm/Group Description:
All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
Overall Number of Participants Analyzed 14 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
0.43
(0.18 to 0.71)
0.50
(0.13 to 0.99)
4.Secondary Outcome
Title Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI
Hide Description The median percent change in the volume of the target vestibular schwannoma using volumetric MRI
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Hide Arm/Group Description:
All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months.
All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
Overall Number of Participants Analyzed 14 2
Median (Full Range)
Unit of Measure: percentage of change in tumor volume
0.5
(-29 to 41)
10.8
(3.4 to 18.2)
5.Secondary Outcome
Title Number of Participants With Changes in Function of the Auditory System
Hide Description The primary distortion product optoacoustic emissions (DPOAE) measurement will be treated non-parametrically (present or absent across time) DPOAE's will be considered present at the frequency of F2 when the distortion product is 6dB above the noise floor. Variables will be analyzed for differences using t-tests if the effects and sample sizes warrant, but this may not be advisable given the small numbers to be accrued.
Time Frame Baseline to 6 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Distortion product optoacoustic emissions (DPOEs) were only obtained for participants at the NCI site; thus, data from 5 participants were analyzed.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Present
3
  60.0%
Absent
2
  40.0%
6.Secondary Outcome
Title Percent Change in Median Vascular Permeability (Ktrans)
Hide Description Correlation assessment were planned for imaging parameters and hearing response based on the estimated changes in Ktrans: a MRI measure of vascular permeability. Only 1/14 participants had complete Ktrans data that was amenable to analysis at baseline and week 72. Hence, these statistical analyses were not possible.
Time Frame Baseline to week 72
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percent change in median Ktrans
-20
7.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: units on a scale
77.85
(27.36 to 98.19)
8.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: T-score
Physical Component Summary (PCS)
50.67
(22.80 to 61.05)
Mental Component Summary
50.79
(33.01 to 56.58)
9.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 1 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
80.56
(26.25 to 95.97)
10.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: T-score
Physical Component Score (PCS)
52.23
(22.73 to 60.45)
Mental component Summary (MCS)
54.30
(36.22 to 59.22)
11.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
75.97
(35.42 to 95.42)
12.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: T-score
Physical Component Summary (PCS)
47.88
(19.98 to 62.34)
Mental Component Summary (MCS)
56.62
(21.10 to 60.94)
13.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
75.28
(51.67 to 92.64)
14.Secondary Outcome
Title Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores
Hide Description The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: T-score
Physical Component Summary (PCS)
51.73
(21.07 to 60.02)
Mental Component Summary (MCS)
51.51
(26.94 to 67.78)
15.Secondary Outcome
Title Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)
Hide Description The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Each response is recorded on an 11 point scale (0 - 10), with the anchor points "not at all" (= 0) and "perfectly" (=10). A higher score indicates better hearing. The median score is reported for each subscale. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: units on a scale
Speech Understanding
3.2
(0.9 to 6.9)
Spatial Location of Sounds
3.2
(0.3 to 8.6)
Qualities of Sounds
4.7
(3.1 to 8.9)
16.Secondary Outcome
Title Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)
Hide Description The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points "not at all" (= 0) and "perfectly" (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
At this time point, one participant was off study due to adverse events and did not complete the questionnaire. Three participants did not complete the questionnaire at this time point. Hence, data from 10 participants were available for analysis.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: units on a scale
Speech Understanding
4.2
(1.3 to 6.8)
Spatial Location of Sounds
4.0
(0.9 to 7.2)
Qualities of Sounds
6.8
(3.1 to 8.2)
17.Secondary Outcome
Title Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)
Hide Description The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points "not at all" (= 0) and "perfectly" (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
Speech Understanding
5.4
(2.9 to 8.1)
Spatial Location of Sounds
4.8
(1.6 to 9.4)
Qualities of Sounds
6.9
(3.1 to 9.7)
18.Secondary Outcome
Title Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)
Hide Description The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points "not at all" (= 0) and "perfectly" (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
Speech Understanding
4.1
(2.1 to 7.4)
Spatial Location of Sounds
3.6
(0.2 to 9.4)
Qualities of Sounds
6.3
(3.2 to 9.6)
19.Secondary Outcome
Title Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)
Hide Description The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: units on a scale
18
(0 to 81)
20.Secondary Outcome
Title Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)
Hide Description The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. One participant did not complete this questionnaire at this time point. Hence, data from 12 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: units on a scale
18
(0 to 43)
21.Secondary Outcome
Title Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)
Hide Description The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
10
(0 to 56)
22.Secondary Outcome
Title Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)
Hide Description The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 - 104 with higher scores indicating more distress related to tinnitus.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
At this time point, one participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.
Arm/Group Title Treatment (Bevacizumab) - All Participants
Hide Arm/Group Description:
Bevacizumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: units on a scale
23
(0 to 40)
Time Frame From first dose until 6 months off of drug or until resolution of all SAE to baseline, assessed up to 12 months
Adverse Event Reporting Description definition is that used in clinicaltrials.gov
 
Arm/Group Title Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Hide Arm/Group Description All enrolled participants received bevacizumab 7.5mg/kg IV once every 3 weeks for up to 12 months. All enrolled patients < 18 years of age received bevacizumab 7.5mg/kg IV once every 3 weeks for 12 months.
All-Cause Mortality
Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/2 (0.00%)    
Blood and lymphatic system disorders     
Idiopathic thrombocytopenia purpura  1  1/14 (7.14%)  1 0/2 (0.00%)  0
Vascular disorders     
Hypertension  1  1/14 (7.14%)  2 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Bevacizumab) - All Participants Treatment (Bevacizumab) - Pediatric Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/14 (92.86%)      1/2 (50.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/14 (7.14%)  1 0/2 (0.00%) 
Hemolysis  1  1/14 (7.14%)  1 0/2 (0.00%) 
Cardiac disorders     
Palpitations  1  2/14 (14.29%)  2 0/2 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/14 (7.14%)  1 1/2 (50.00%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/14 (14.29%)  2 0/2 (0.00%) 
Diarrhea  1  3/14 (21.43%)  3 1/2 (50.00%)  1
Dyspepsia  1  2/14 (14.29%)  2 0/2 (0.00%) 
Hemorrhoidal hemorrhage  1  2/14 (14.29%)  2 0/2 (0.00%) 
Mucositis oral  1  1/14 (7.14%)  1 0/2 (0.00%) 
Nausea  1  4/14 (28.57%)  7 1/2 (50.00%)  1
Oral hemorrhage  1  2/14 (14.29%)  2 0/2 (0.00%) 
Oral pain  1  1/14 (7.14%)  1 0/2 (0.00%) 
Rectal hemorrhage  1  1/14 (7.14%)  1 0/2 (0.00%) 
Vomiting  1  1/14 (7.14%)  1 0/2 (0.00%) 
Weight loss  1  1/14 (7.14%)  1 0/2 (0.00%) 
General disorders     
Fatigue  1  9/14 (64.29%)  13 1/2 (50.00%)  2
Injury, poisoning and procedural complications     
Bruising  1  2/14 (14.29%)  2 0/2 (0.00%) 
Wound complication  1  1/14 (7.14%)  1 0/2 (0.00%) 
Investigations     
ALT increased  1  5/14 (35.71%)  8 0/2 (0.00%) 
AST increase  1  4/14 (28.57%)  8 0/2 (0.00%) 
CPK increase  1  1/14 (7.14%)  1 1/2 (50.00%)  1
Electrocardiogram with prolonged QTc  1  1/14 (7.14%)  1 1/2 (50.00%)  1
Increased blood bicarbonate  1  1/14 (7.14%)  1 0/2 (0.00%) 
Platelet count decreased  1  1/14 (7.14%)  2 1/2 (50.00%)  2
Weight gain  1  1/14 (7.14%)  1 0/2 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/14 (7.14%)  2 0/2 (0.00%) 
Hyperglycemia  1  2/14 (14.29%)  4 0/2 (0.00%) 
Hypermagnesemia  1  2/14 (14.29%)  3 1/2 (50.00%)  2
Nervous system disorders     
Dizziness  1  1/14 (7.14%)  1 0/2 (0.00%) 
Headache  1  1/14 (7.14%)  2 1/2 (50.00%)  2
Peripheral sensory neuropathy  1  1/14 (7.14%)  1 0/2 (0.00%) 
Renal and urinary disorders     
Hemoglobinuria  1  1/14 (7.14%)  1 1/2 (50.00%)  1
Proteinuria  1  2/14 (14.29%)  10 1/2 (50.00%)  6
Reproductive system and breast disorders     
Irregular menstruation  1  2/7 (28.57%)  6 1/2 (50.00%)  4
Menorrhagia  1  1/7 (14.29%)  3 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/14 (7.14%)  1 1/2 (50.00%)  1
Dyspnea  1  2/14 (14.29%)  2 1/2 (50.00%)  1
Epistaxis  1  7/14 (50.00%)  10 1/2 (50.00%)  1
Hoarseness  1  1/14 (7.14%)  1 1/2 (50.00%)  1
Nasal septum perforation  1  1/14 (7.14%)  1 0/2 (0.00%) 
Sore throat  1  2/14 (14.29%)  4 1/2 (50.00%)  2
Voice alteration  1  1/14 (7.14%)  1 0/2 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  2/14 (14.29%)  2 1/2 (50.00%)  1
Vascular disorders     
Hypomagnesemia  1  1/14 (7.14%)  1 0/2 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by 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
Layout table for Results Point of Contact information
Name/Title: Dr. Jaishri Blakeley
Organization: Johns Hopkins Comprehensive Neurofibromatosis Center
Phone: 410-614-3853
EMail: jblakel3@jhmi.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01207687    
Obsolete Identifiers: NCT01204463
Other Study ID Numbers: NCI-2012-02987
NCI-2012-02987 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
J1002
NA_00034732 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Cancer Center )
8248 ( Other Identifier: CTEP )
P30CA006973 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2010
First Posted: September 23, 2010
Results First Submitted: May 18, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 27, 2018