Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Recurrent Respiratory Papillomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02555800
• Other study ID #: INER
• Status: Recruiting
• Phase: Phase 2
• First received: August 12, 2015
• Last updated: July 25, 2016
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: Centro de Investigación en. Enfermedades Infecciosas, Mexico
• Contact: Yuria Ablanedo-Terrazas, M.D.
• Phone: +525556667985
• Email: yuria.ablanedo[@]cieni.org.mx
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Intervention

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.
• 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:
• Placebo
Saline solution

Locations

Country	Name	City	State
Mexico	Centro de Investigacion en Enfermedades Infecciosas	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Investigación en. Enfermedades Infecciosas, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the annual surgery rate	Changes in the annual surgery rate before and after intervention	12 months	No
Primary	Severity of airway affection measured by the Derkay papilloma severity grading scale	Changes in the Derkay papilloma severity grading scale before and after intervention	12 months	No
Secondary	Hoarseness severity measured by the Voice Handicap Index	Changes in the Voice Handicap Index before and after intervention	12 months	No
Secondary	Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)	Adverse events	12 months	Yes