Avelumab for People With Recurrent Respiratory Papillomatosis
Status:
Completed
Trial end date:
2021-09-15
Target enrollment:
Participant gender:
Summary
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus.
It can cause voice changes, airway compromise, pulmonary lesions, and cancers. Programmed
death-ligand 1 (PD-L1) is a protein on cells. It may be able to stop or decrease the immune
system s response to viruses such as human papillomavirus. The drug Avelumab interferes with
the activity of PD-L1. Researchers want to see if Avelumab treats RRP and study its side
effects.
Objective:
To see if Avelumab works in treating RRP and is safe.
Eligibility:
People ages 18 and older with aggressive RRP that has not responded to available treatments
Design:
Participants will be screened with:
Medical history
Previously collected tumor tissue
Physical exam
Blood, urine, and heart tests
Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx,
and upper windpipe.
Before starting treatment, participants will have:
Endoscopy under anesthesia. A sample of papilloma will be taken.
Voice handicap questionnaire
Computed tomography (CT) scans
Apheresis: An intravenous (IV) is inserted into an arm vein. White blood cells are separated
from the rest of the blood and stored for research. The rest of the blood is returned through
the same IV or one in the other arm.
Participants will get the study drug by IV every 2 weeks for up to 12 weeks.
Participants will repeat the previous tests throughout the study.
If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then
every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses.
Participants will be evaluated 30 days after their last infusion. They will then be contacted
annually.