Recurrent Respiratory PapillomatosisPhase 2NCT02555800
Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis
A Phase 2 study testing Bevacizumab and Cidofovir in people with Recurrent Respiratory Papillomatosis, run by Centro de Investigación en. Enfermedades Infecciosas, Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Respiratory Papillomatosis
- What is being tested?
- Bevacizumab and Cidofovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2014to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with recurrent respiratory papillomatosis proven by biopsy.
- Patients with 2 or more previous surgeries for papillomatosis
Who cannot join
- Patients with heart or renal disease
- Patients who receive another adjuvant therapy
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, 14080
Gustavo Reyes-Teran, M.D., +52(55)56667985
Yuria Ablanedo-Terrazas, M.D., +52(55)56667985
About this study
Official title: Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Read the 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.
- Conditions
- Recurrent Respiratory Papillomatosis
- Being tested
- Bevacizumab, Cidofovir, Placebo
- Keywords
- Laryngeal papillomatosis, Cidofovir, Bevacizumab, Recurrent respiratory papillomatosis
- Medical subject headings
- Recurrent respiratory papillomatosis, Laryngeal papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
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.
CidofovirDrug
Also called Vistide
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.
PlaceboOther
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the annual surgery rate
Changes in the annual surgery rate before and after intervention
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Hoarseness severity measured by the Voice Handicap Index
Changes in the Voice Handicap Index before and after intervention
Measured: 12 months
Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)
Adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Investigators
- Gustavo Reyes-Terán, M.D., Principal investigator, Centro de Investigación en. Enfermedades Infecciosas, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555800
- Sponsor's protocol ID
- INER
- Status last verified
- Jul 2016
- First submitted
- 12 Aug 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35397828
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02555800
- Acronym / sponsor ID
- INER
- Conditions
- Recurrent Respiratory Papillomatosis
- Keywords
- Laryngeal papillomatosis, Cidofovir, Bevacizumab, Recurrent respiratory papillomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, MexicoOther government
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabPatients 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 | Experimental | Drug: CidofovirPatients 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. |
| Saline | Placebo comparator | Other: PlaceboPatients will receive 3 intralesional injections of 3.5 mL of saline solution every 3 to 6 weeks in a submucosal plane after surgical debulking. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with recurrent respiratory papillomatosis proven by biopsy.
- Patients with 2 or more previous surgeries for papillomatosis
Key exclusion criteria (2 listed)
- Patients with heart or renal disease
- Patients who receive another adjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinPatients 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 |
| CidofovirAlso: VistidePatients 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 |
| PlaceboSaline solution | Other | Saline |
Primary outcome
Changes in the annual surgery rate
Time frame: 12 months
Changes in the annual surgery rate before and after intervention
Severity of airway affection measured by the Derkay papilloma severity grading scale
Time frame: 12 months
Changes in the Derkay papilloma severity grading scale before and after intervention
2 secondary outcomes
Hoarseness severity measured by the Voice Handicap Index
Time frame: 12 months
Number of Treatment-Related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Derived from this study: PubMed 35397828Ablanedo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Reyes-Terán, M.D. principal investigator
Centro de Investigación en. Enfermedades Infecciosas, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Cidofovir in people with Recurrent Respiratory Papillomatosis, run by Centro de Investigación en. Enfermedades Infecciosas, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuria Ablanedo-Terrazas, M.D. (+525556667985, yuria.ablanedo@cieni.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the annual surgery rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.