Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis
NCT ID: NCT02555800
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
36 participants
INTERVENTIONAL
2014-12-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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
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.
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
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.
Placebo
Saline solution
Interventions
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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
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
Saline solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with 2 or more previous surgeries for papillomatosis
Exclusion Criteria
* Patients who receive another adjuvant therapy
ALL
No
Sponsors
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Centro de Investigación en. Enfermedades Infecciosas, Mexico
OTHER_GOV
Responsible Party
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Gustavo Reyes-Teran
M.D.
Principal Investigators
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Gustavo Reyes-Terán, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Locations
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Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, Mexico
Countries
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Central Contacts
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Facility Contacts
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Gustavo Reyes-Teran, M.D.
Role: primary
Yuria Ablanedo-Terrazas, M.D.
Role: backup
References
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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.
Other Identifiers
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INER
Identifier Type: -
Identifier Source: org_study_id
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