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Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

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ClinicalTrials.gov Identifier: NCT02555800
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico

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.

Condition or disease Intervention/treatment Phase
Recurrent Respiratory Papillomatosis Drug: Bevacizumab Drug: Cidofovir Other: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Avastin

Experimental: 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.
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.
Other Name: Vistide

Placebo Comparator: 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.
Other: Placebo
Saline solution




Primary Outcome Measures :
  1. Changes in the annual surgery rate [ Time Frame: 12 months ]
    Changes in the annual surgery rate before and after intervention

  2. Severity of airway affection measured by the Derkay papilloma severity grading scale [ Time Frame: 12 months ]
    Changes in the Derkay papilloma severity grading scale before and after intervention


Secondary Outcome Measures :
  1. Hoarseness severity measured by the Voice Handicap Index [ Time Frame: 12 months ]
    Changes in the Voice Handicap Index before and after intervention

  2. Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 12 months ]
    Adverse events



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555800


Contacts
Contact: Yuria Ablanedo-Terrazas, M.D. +525556667985 yuria.ablanedo@cieni.org.mx

Locations
Mexico
Centro de Investigacion en Enfermedades Infecciosas Recruiting
Mexico, Mexico, 14080
Contact: Gustavo Reyes-Teran, M.D.    +52(55)56667985      
Contact: Yuria Ablanedo-Terrazas, M.D.    +52(55)56667985      
Principal Investigator: Gustavo Reyes-Teran, M.D.         
Sub-Investigator: Yuria Ablanedo-Terrazas, M.D.         
Sub-Investigator: Arturo Ramírez-García, M.D.         
Sub-Investigator: Oscar Estrada-Camacho, M.D.         
Sub-Investigator: Gabriel Tona-Acedo, M.D.         
Sponsors and Collaborators
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Investigators
Principal Investigator: Gustavo Reyes-Terán, M.D. Centro de Investigación en. Enfermedades Infecciosas, Mexico

Responsible Party: Gustavo Reyes-Teran, M.D., Centro de Investigación en. Enfermedades Infecciosas, Mexico
ClinicalTrials.gov Identifier: NCT02555800     History of Changes
Other Study ID Numbers: INER
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico:
Laryngeal papillomatosis
Cidofovir
Bevacizumab
Recurrent respiratory papillomatosis

Additional relevant MeSH terms:
Papillomavirus Infections
Papilloma
Respiratory Tract Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Pharmaceutical Solutions
Bevacizumab
Cidofovir
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents