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Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Primary Purpose

Recurrent Respiratory Papillomatosis

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Bevacizumab
Cidofovir
Placebo
Sponsored by
Centro de Investigación en. Enfermedades Infecciosas, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Respiratory Papillomatosis focused on measuring Laryngeal papillomatosis, Cidofovir, Bevacizumab, Recurrent respiratory papillomatosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Investigacion en Enfermedades InfecciosasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Bevacizumab

Cidofovir

Saline

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hoarseness severity measured by the Voice Handicap Index
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)
Adverse events

Full Information

First Posted
August 12, 2015
Last Updated
July 25, 2016
Sponsor
Centro de Investigación en. Enfermedades Infecciosas, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02555800
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Investigación en. Enfermedades Infecciosas, Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Respiratory Papillomatosis
Keywords
Laryngeal papillomatosis, Cidofovir, Bevacizumab, Recurrent respiratory papillomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Cidofovir
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cidofovir
Other Intervention Name(s)
Vistide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
Changes in the annual surgery rate
Description
Changes in the annual surgery rate before and after intervention
Time Frame
12 months
Title
Severity of airway affection measured by the Derkay papilloma severity grading scale
Description
Changes in the Derkay papilloma severity grading scale before and after intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hoarseness severity measured by the Voice Handicap Index
Description
Changes in the Voice Handicap Index before and after intervention
Time Frame
12 months
Title
Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)
Description
Adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuria Ablanedo-Terrazas, M.D.
Phone
+525556667985
Email
yuria.ablanedo@cieni.org.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Reyes-Terán, M.D.
Organizational Affiliation
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigacion en Enfermedades Infecciosas
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Reyes-Teran, M.D.
Phone
+52(55)56667985
First Name & Middle Initial & Last Name & Degree
Yuria Ablanedo-Terrazas, M.D.
Phone
+52(55)56667985
First Name & Middle Initial & Last Name & Degree
Gustavo Reyes-Teran, M.D.
First Name & Middle Initial & Last Name & Degree
Yuria Ablanedo-Terrazas, M.D.
First Name & Middle Initial & Last Name & Degree
Arturo Ramírez-García, M.D.
First Name & Middle Initial & Last Name & Degree
Oscar Estrada-Camacho, M.D.
First Name & Middle Initial & Last Name & Degree
Gabriel Tona-Acedo, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
35397828
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.
Results Reference
derived
PubMed Identifier
34154795
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.
Results Reference
derived

Learn more about this trial

Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

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