Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven M. Zeitels, MD, FACS, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01020747
First received: November 13, 2009
Last updated: December 18, 2012
Last verified: December 2012
Results First Received: April 23, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Respiratory Papillomatosis
Interventions: Drug: Avastin® (bevacizumab)
Drug: Saline

  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
No text entered.

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
Group Avastin Subjects received Avastin in the more diseased vocal fold and saline in the other.

Participant Flow:   Overall Study
    Group Avastin  
STARTED     20  
COMPLETED     19  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Group Avastin Subjects received Avastin in the more diseased vocal fold and saline in the other.

Baseline Measures
    Group Avastin  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.5  ± 8.6  
Gender  
[units: participants]
 
Female     3  
Male     17  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period.   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Monica Tettamanti
Organization: Massachusetts General Hospital
phone: 617-643-5696
e-mail: mtettamanti@ccib.mgh.harvard.edu


Publications:


Responsible Party: Steven M. Zeitels, MD, FACS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01020747     History of Changes
Other Study ID Numbers: VC-P001
Study First Received: November 13, 2009
Results First Received: April 23, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration