Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Phase 2

• Conditions: Recurrent Respiratory Papillomatosis
• Interventions: Other: Placebo; Drug: Bevacizumab; Drug: Cidofovir

• Registration Number: NCT02555800
• Lead Sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico

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 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-09-19
• Study First Posted: 2015-09-22
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients diagnosed with recurrent respiratory papillomatosis proven by biopsy.
• Patients with 2 or more previous surgeries for papillomatosis

Exclusion Criteria

• Patients with heart or renal disease
• Patients who receive another adjuvant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Patients will receive 3 intralesional injections of 3.5 mL of saline solution every 3 to 6 weeks in a submucosal plane after surgical debulking.
Bevacizumab	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.
Cidofovir	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.

Primary Outcome Measures

Name	Time	Method
Changes in the annual surgery rate	12 months	Changes in the annual surgery rate before and after intervention
Severity of airway affection measured by the Derkay papilloma severity grading scale	12 months	Changes in the Derkay papilloma severity grading scale before and after intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro de Investigacion en Enfermedades Infecciosas; 🇲🇽 Mexico, Mexico