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ACTIVE NOT RECRUITING
NCT05797246
PHASE2

Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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....

Official title: A Phase II Study of Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2023-08-02

Completion Date

2029-01-01

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Bevacizumab

10 mg/kg IV every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States