Clinical trial NCT02555800: Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis
Official title: Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Respiratory Papillomatosis
Keywords: Laryngeal papillomatosis
Cidofovir
Bevacizumab
Recurrent respiratory papillomatosis
Lead sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico
Sponsor class: OTHER_GOV
First posted: 2015-09-22
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the annual surgery rate
timeFrame: 12 months
measure: Severity of airway affection measured by the Derkay papilloma severity grading scale
timeFrame: 12 months
Secondary outcomes:
measure: Hoarseness severity measured by the Voice Handicap Index
timeFrame: 12 months
measure: Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Centro de Investigacion en Enfermedades Infecciosas
Study officials:
affiliation: Centro de Investigación en. Enfermedades Infecciosas, Mexico
name: Gustavo Reyes-Terán, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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). 2021 Jun 18:S0001-6519(21)00030-3. doi: 10.1016/j.otorri.2020.12.001. Online ahead of print. English, Spanish.