Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Sponsor
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Study ID
NCT02555800
Phase
PHASE2
Status
Unknown

Conditions

  • Recurrent Respiratory Papillomatosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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 — DRUG
    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 — OTHER
    Saline solution

Study Details

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.

Key Dates

First listed
Sep 22, 2015
Start date
Dec 31, 2014
Status verified
Jul 2016
Primary completion
Dec 31, 2016
Completion
Jun 30, 2017

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Changes in the annual surgery rate [ Time Frame: 12 months ]

Central Contacts

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