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Active Not Recruiting NCT05797246

Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Conditions: Respiratory Tract Diseases, Neoplasms, Neoplasms by Histologic Type, Neoplasms, Glandular and Epithelial, Neoplasms, Squamous Cell, Tumor Virus Infections, Infections, Virus Diseases, DNA Virus Infections, Pathologic Processes, Disease Attributes, Recurrence, Papilloma, Respiratory Tract Infections, Papillomavirus Infections

Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 21
Sponsor: National Cancer Institute (NCI)

Location: National Institutes of Health Clinical Center Bethesda Maryland

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....

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 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 \

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Source: ClinicalTrials.gov (NCT05797246). StuddyBuddy aggregates publicly available trial information.