Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Launched by NATIONAL CANCER INSTITUTE (NCI) · Apr 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called bevacizumab to see if it can help reduce the number of surgeries needed for adults with recurrent respiratory papillomatosis (RRP), a rare condition that causes wart-like growths in the airways. People aged 18 and older who have been diagnosed with RRP and require surgery to remove these growths may be eligible to participate. Candidates should have had at least two surgeries in the past year to control their RRP symptoms and meet certain health criteria.

If you join the trial, you will receive surgery to remove the growths, followed by 11 doses of bevacizumab delivered through an IV in your arm. You’ll visit the clinic for these treatments, which will take about 8 hours each time. Additionally, some participants may undergo a procedure to collect blood for research purposes. After your last treatment, doctors will follow up with you for a year to monitor your health. This trial aims to find better treatment options for people with RRP, making it an important step in improving care for this condition.

Gender

ALL

Eligibility criteria

• * 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.