Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Respiratory Papillomatosis

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Cidofovir
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>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: Bevacizumab<br>* 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.<br>* Other names: Avastin;|
| Experimental: Cidofovir<br>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. | Drug: Cidofovir<br>* 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.<br>* Other names: Vistide;|
| Placebo Comparator: Saline<br>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. | Other: Placebo<br>* Saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the annual surgery rate | Changes in the annual surgery rate before and after intervention | 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 | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cidofovir, Laryngeal papillomatosis, Bevacizumab, Recurrent respiratory papillomatosis