Clinical Trial: Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial

Brief Summary: The aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in patients with recurrent respiratory papillomatosis.

Detailed Summary: The investigators designed a randomized, double-blind, placebo-controlled study. Children and adults will be randomized to receive either 3 dosis of intralesional bevacizumab, cidofovir or saline solution. Primary endpoints are the assessment of changes in the annual surgery rate and Derkay papilloma severity grading scale; secondary endpoints are changes in the Voice Handicap Index and safety.
Sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico

Current Primary Outcome:

  • Changes in the annual surgery rate [ Time Frame: 12 months ]
    Changes in the annual surgery rate before and after intervention
  • Severity of airway affection measured by the Derkay papilloma severity grading scale [ Time Frame: 12 months ]
    Changes in the Derkay papilloma severity grading scale before and after intervention


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hoarseness severity measured by the Voice Handicap Index [ Time Frame: 12 months ]
    Changes in the Voice Handicap Index before and after intervention
  • Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 12 months ]
    Adverse events


Original Secondary Outcome: Same as current

Information By: Centro de Investigación en. Enfermedades Infecciosas, Mexico

Dates:
Date Received: August 12, 2015
Date Started: December 2014
Date Completion: June 2017
Last Updated: July 25, 2016
Last Verified: July 2016