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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02555800
Other study ID # INER
Secondary ID
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


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
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