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NCT06412172
Recurrent respiratory papillomatosis (RRP) is an orphan disease that affects approximately 20,000 people in the United States and is caused by infection with human papillomavirus (HPV) types 6 and 11. Since RRP is an orphan disease, it is an understudied disease entity with correspondingly few treatment options. The investigators hypothesize that by understanding the biology of RRP and the failed host immune responses against HPV, novel and rational therapies can be developed. This study will examine the genetic and immunologic alterations found in these rare tumors and distant metastatic involved sites (such as the lung) in patients diagnosed with RRP.
NCT03707587
Background: Programmed cell death protein 1 (PD-L1) is a protein on the surface of cells. It regulates if a cell can be killed by immune system cells. It is thought to be able to affect the immune system response to diseased cells like those infected with a virus. The molecule M7824 interferes with the activity of PD-L1. It could help the immune system kill cells infected with a virus . Since recurrent respiratory papillomatosis is caused by a virus infection, this molecule could help. Objective: To see if M7824 works in treating recurrent respiratory papillomatosis. Eligibility: Adults ages 18 years or older with recurrent respiratory papillomatosis Design: Participants will be screened with: Medical history Physical exam Blood and pregnancy tests Endoscopy procedure in clinic. A small tube with a camera will look at the inside of the nose, throat, larynx, and upper windpipe. Some participants will also be screened with a chest scan. At the start of the study, participants will: Have a sedated endoscopy procedure where biopsies will be taken. Have blood tests. Have apheresis. Blood will be collected by a tube in an arm vein. A machine will remove white blood cells. The rest of the blood will be returned into an arm vein. Fill out a voice questionnaire. Participants will get the study molecule into a vein over about 1 hour. They will get it every other week for up to 12 weeks. Participants will repeat screening and starting procedures throughout the study. They will also review side effects and any medicine they are taking. When they are done with the study treatment, participants will be evaluated by repeating the study procedures. They may be evaluated periodically until their disease progresses.
NCT03465280
Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment. Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.
NCT02859454
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.
NCT02854761
This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.
NCT01995721
Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process. After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.
NCT00038714
Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.