NCT02555800

Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Recurrent Respiratory Papillomatosis

Interventions

Type	Name	Description
DRUG	Bevacizumab	Patients will receive 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) every 3 to 6 weeks in a submucosal plane after surgical debulking. 12.5 mg of bevacizumab diluted in 3mL of 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.
DRUG	Cidofovir	Patients will receive 3 intralesional injections of cidofovir every 3 to 6 weeks a submucosal plane after surgical debulking. 3.5 mL of cidofovir diluted to a concentration of 5 mg/mL in a 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.
OTHER	Placebo	Saline solution

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2015-09-22
• Last updated: 2016-07-26

Locations

1 site across 1 country: Mexico