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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
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.
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.
Saline solution
Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, Mexico
RECRUITINGChanges in the annual surgery rate
Changes in the annual surgery rate before and after intervention
Time frame: 12 months
Severity of airway affection measured by the Derkay papilloma severity grading scale
Changes in the Derkay papilloma severity grading scale before and after intervention
Time frame: 12 months
Hoarseness severity measured by the Voice Handicap Index
Changes in the Voice Handicap Index before and after intervention
Time frame: 12 months
Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)
Adverse events
Time frame: 12 months
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