Recurrent Respiratory Papillomatosis
Conditions
Keywords
Laryngeal papillomatosis, Cidofovir, Bevacizumab, Recurrent respiratory papillomatosis
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.
Interventions
DRUGBevacizumab
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.
DRUGCidofovir
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.
OTHERPlacebo
Saline solution
Sponsors
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the annual surgery rate | 12 months | Changes in the annual surgery rate before and after intervention |
| Severity of airway affection measured by the Derkay papilloma severity grading scale | 12 months | Changes in the Derkay papilloma severity grading scale before and after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hoarseness severity measured by the Voice Handicap Index | 12 months | 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) | 12 months | Adverse events |
Countries
Mexico
Contacts
Primary ContactYuria Ablanedo-Terrazas, M.D.
Outcome results
None listed