Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP) (NCT05797246) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
United States21 participantsStarted 2023-08-02
Plain-language summary
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed.
Objective:
To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP.
Eligibility:
People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways.
Design:
Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest.
Participants will have surgery to remove the growths in their airways.
Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours.
Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia.
Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle.
Follow-up will continue for 1 year after the last treatment.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Age \>= 18 years old.
* Histologically confirmed diagnosis of RRP.
* Individuals must require procedure(s) to remove papillomatous disease per standard of care.(not required for re-treatment)
* A history of 2 or more surgeries within 12 months prior to treatment initiation in order to control laryngeal and/or tracheal RRP (not required for re-treatment).
* At least one of the following (not required for re-treatment):
* A Derkay score of 8 or greater
* Measurable disease per RECIST 1.1 (participants with pulmonary RRP only)
* Tracheal involvement with RRP that has required two or more clinical interventions in the last 12 months (two or more clinical interventions)
* Tracheostomy.
* ECOG performance status of 0-1.
* Individuals must have adequate organ and marrow function as defined below:
* White blood cells (WBC): \>2,000/microL
* Absolute neutrophil count (ANC): \>=1,500/microL
* Hemoglobin: \>9.0 g/dL
* Platelets: \>=100,000/microL
* Total bilirubin: \<=1.5 mg/dL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL
* Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT): \<=2.5 X institutional upper limit of normal (ULN)
* Creatinine: within normal institutional limits
OR
Creatinine Clearance (CrCl): \>=60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal (calculated using the Cockcroft-Gault formula).
* Prothrombin time (PT) /Inte…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab.