Drug could slash surgeries for rare airway disease
NCT ID NCT05797246
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 8 times
Summary
This phase II trial tests whether bevacizumab, a drug that blocks blood vessel growth, can lengthen the time between surgeries for adults with recurrent respiratory papillomatosis (RRP), a rare condition causing wart-like growths in the airways. Participants receive 11 doses of the drug over about a year after surgery to remove growths. The goal is to see if the treatment reduces how often surgery is needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bevacizumab
- What this could lead to
- If it works, this could mean fewer surgeries for people with RRP, helping them breathe and speak more easily.
- What could go wrong
- This is a small, early-phase trial with only 21 participants, so results may not apply to everyone. Bevacizumab can cause side effects like high blood pressure or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
21 people
The number who actually took part.
- Started
-
Aug 2023
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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) /International normalized ratio (INR) and Partial thromboplastin time (PTT): \<=1 X institutional ULN. In participants on anticoagulation, coagulation tests should be within a therapeutic range. * Urinalysis: Urine dipstick \< 2+ proteinuria. In participants with \>=2+ proteinuria on dipstick urinalysis should undergo a 24-hour urine collection and must demonstrate \<=1g of protein in 24 hours to be eligible * Individuals must have received their last systemic therapy for RRP \> 4 weeks or 5 half-lives, whichever is longer, prior to treatment initiation, except for systemic bevacizumab which must be \> 1 year prior to treatment initiation (not applicable for re-treatment) * Individuals able to become pregnant and their partners must agree to use highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization ) for the duration of bevacizumab treatment and up to 6 months after completion of bevacizumab treatment. NOTE: Abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the individual is also acceptable. * Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 6 months after bevacizumab treatment discontinuation. * All individuals must have the ability to understand and willingness to sign a written informed consent. * All individuals must be willing to undergo mandatory biopsy during the study (not applicable for re-treatment). EXCLUSION CRITERIA: * History of significant (i.e., active) cardiovascular disease or thromboembolic event: cerebral vascular accident/stroke (within 6 months prior to treatment initiation), myocardial infarction (within 6 months prior to treatment initiation), unstable angina, congestive heart failure (\>= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication as assessed by EKG. * History of abdominal fistula or gastrointestinal perforation within 6 months prior to treatment initiation. * Major surgery within 4 weeks prior to treatment initiation. * Non-healing wound, active ulcer, or untreated bone fracture. * History of hemoptysis (\>2.5 mL of bright red blood per episode) within 1 month prior to treatment initiation. * Evidence of bleeding diathesis or significant coagulopathy (with or without current therapeutic anticoagulation). * Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to treatment initiation. * Inadequately controlled hypertension (defined as systolic blood pressure (BP) \>150 mmHg and/or diastolic blood pressure \> 100 mmHg), an average of 3 BP readings on 2 sessions will be used to measure blood pressure if initial reading indicates inadequately controlled hypertension. NOTE: Anti-hypertensive therapy to achieve blood pressures below these parameters is allowed. * Prior history of hypertensive crisis or hypertensive encephalopathy. * Persisting toxicity related to prior therapy of Grade \>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. NOTE: alopecia, sensory neuropathy Grade \<=2 are acceptable. * Known active alcohol or drug abuse. * History of allergy to study drug components. * Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in WOCBP performed at screening). * Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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