Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

NCT02555800 — Phase 2, Unknown, 36 participants, Centro de Investigación en. Enfermedades Infecciosas, Mexico

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

Registry	NCT02555800
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	36 (Estimated)
Sponsor	Centro de Investigación en. Enfermedades Infecciosas, Mexico (Other gov)
Conditions	Recurrent Respiratory Papillomatosis
Interventions	Bevacizumab, Cidofovir, Placebo (Drug, other)
Dates	start 2014-12-01, primary completion 2016-12-01 (estimated), completion 2017-06-01 (estimated), first posted 2015-09-22, last updated 2016-07-26
Locations	1 site in Mexico

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Bevacizumab	Experimental	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.
Cidofovir	Experimental	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.
Saline	Placebo comparator	Other: 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 (Drug), also known as Avastin: 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 (Drug), also known as Vistide: 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.
Placebo (Other): Saline solution

+Outcome measures

Primary outcomes

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 outcomes

Hoarseness severity measured by the Voice Handicap Index [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) [12 months]: Adverse events

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Centro de Investigacion en Enfermedades Infecciosas	México, State of Mexico	Mexico	Recruiting

+Publications

Results publication: Ablanedo-Terrazas Y, Estrada-Camacho O, Alvarado-de la Barrera C, Ramirez-Garcia A, Tona-Acedo G, Bross-Soriano D, Schimelmitz-Idi J. Efficacy of cidofovir versus bevacizumab in recurrent respiratory papillomatosis: A randomized, double-blind, placebo-controlled pilot study. Acta Otorrinolaringol Esp (Engl Ed). 2022 Mar-Apr;73(2):82-88. doi: 10.1016/j.otoeng.2020.12.001. PMID 35397828

+Investigators

Gustavo Reyes-Terán, M.D., Principal investigator, Centro de Investigación en. Enfermedades Infecciosas, Mexico