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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207687
First Posted: September 23, 2010
Last Update Posted: August 17, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: May 18, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Bevacizumab) - All Participants 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.

Participant Flow:   Overall Study
    Treatment (Bevacizumab) - All Participants
STARTED   14 
COMPLETED   12 
NOT COMPLETED   2 
Adverse Event                1 
Withdrawal by Subject                1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Treatment (Bevacizumab) People with NF2, not eligible for surgery with progressive vestibular schwannoma

Baseline Measures
   Treatment (Bevacizumab) 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      2  14.3% 
Between 18 and 65 years      11  78.6% 
>=65 years      1   7.1% 
Age 
[Units: Years]
Median (Full Range)
 30.5 
 (14 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  71.4% 
Male      4  28.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
 
United States   14 
Karnofsky performance status scale [1] 
[Units: Units on a scale]
Median (Full Range)
 80 
 (70 to 90) 
[1] 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] 
[Units: Units on a scale]
Median (Full Range)
 60.5 
 (13 to 82) 
[1] 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


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Hearing Response   [ Time Frame: Baseline to 12 months ]

2.  Secondary:   Incidence of Serious or Life Threatening Toxicities   [ Time Frame: Up to 6 months post-treatment ]

3.  Secondary:   Radiographic Response   [ Time Frame: Baseline to 6 months post-treatment ]

4.  Secondary:   Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI   [ Time Frame: Baseline to 12 months ]

5.  Secondary:   Changes in Function of the Auditory System   [ Time Frame: Baseline to 6 months post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

6.  Secondary:   Change in Vascular Permeability (Ktrans), Relative Cerebral Blood Volume/Flow, Mean Transit Time, and Mean Vessel Diameter From Perfusion-weighted MRI   [ Time Frame: Baseline to week 72 ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

7.  Secondary:   Quality of the Life, Assessed Using Health Survey Short Form-36 (SF-36), Speech and Spatial Qualities Questionnaire (SSQ), and Tinnitus Reaction Questionnaire (TRQ)   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

8.  Secondary:   Quality of the Life, Assessed Using SF-36, SSQ, andTRQ   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

9.  Secondary:   Quality of the Life, Assessed Using SF-36, SSQ, andTRQ   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   01/2018  

10.  Secondary:   Quality of the Life, Assessed Using SF-36, SSQ, andTRQ   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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. Jaishri Blakeley
Organization: Johns Hopkins Comprehensive Neurofibromatosis Center
phone: 410-614-3853
e-mail: jblakel3@jhmi.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01207687     History of Changes
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 17, 2017