Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

July 25, 2016 updated by: Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico, Mexico, 14080
        • Recruiting
        • Centro de Investigacion en Enfermedades Infecciosas
        • Contact:
          • Gustavo Reyes-Teran, M.D.
          • Phone Number: +52(55)56667985
        • Contact:
          • Yuria Ablanedo-Terrazas, M.D.
          • Phone Number: +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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the annual surgery rate
Time Frame: 12 months
Changes in the annual surgery rate before and after intervention
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hoarseness severity measured by the Voice Handicap Index
Time Frame: 12 months
Changes in the Voice Handicap Index before and after intervention
12 months
Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: 12 months
Adverse events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Investigación en. Enfermedades Infecciosas, Mexico

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

September 19, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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