NCT02555800

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

August 12, 2015

Last Update Submit

July 25, 2016

Conditions

Recurrent Respiratory Papillomatosis

Keywords

Laryngeal papillomatosisCidofovirBevacizumabRecurrent respiratory papillomatosis

Outcome Measures

Primary Outcomes (2)

  • Changes in the annual surgery rate

    Changes in the annual surgery rate before and after intervention

    12 months

  • 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

Secondary Outcomes (2)

  • Hoarseness severity measured by the Voice Handicap Index

    12 months

  • Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)

    12 months

Study Arms (3)

Bevacizumab

EXPERIMENTAL

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

Cidofovir

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

BevacizumabDRUG

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.

Also known as: Avastin
Bevacizumab
CidofovirDRUG

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.

Also known as: Vistide
Cidofovir
PlaceboOTHER

Saline solution

Saline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with recurrent respiratory papillomatosis proven by biopsy.
  • Patients with 2 or more previous surgeries for papillomatosis

You may not qualify if:

  • Patients with heart or renal disease
  • Patients who receive another adjuvant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigacion en Enfermedades Infecciosas

México, State of Mexico, 14080, Mexico

RECRUITING

Related Publications (1)

  • Ablanedo-Terrazas Y, Estrada-Camacho O, Alvarado-de la Barrera C, Ramirez-Garcia A, Tona-Acedo G, Bross-Soriano D, Schimelmitz-Idi J. Efficacy of cidofovir versus bevacizumab in recurrent respiratory papillomatosis: A randomized, double-blind, placebo-controlled pilot study. Acta Otorrinolaringol Esp (Engl Ed). 2022 Mar-Apr;73(2):82-88. doi: 10.1016/j.otoeng.2020.12.001.

    PMID: 35397828DERIVED

MeSH Terms

Conditions

Recurrent respiratory papillomatosisLaryngeal papillomatosis

Interventions

BevacizumabCidofovir

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gustavo Reyes-Terán, M.D.

    Centro de Investigación en. Enfermedades Infecciosas, Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuria Ablanedo-Terrazas, M.D.

CONTACT

+525556667985yuria.ablanedo@cieni.org.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 12, 2015

First Posted

September 22, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

ME(1)