Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

• Status: Withdrawn
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• 1. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma

• 2. Child under age 10

• 3. Informed consent and where appropriate informed assent

• 4. Children who have undergone at least 4 documented surgical interventions in the past year.

Exclusion Criteria:

• Parental or child refusal to participate

• Heart failure

• Atrio-ventricular heart block

• Cardiac anomalies

• Low resting heart rate

• Low resting blood pressure

• Wolff-Parkinson White Syndrome

• Unexplained syncope

• Asthma or Reactive airway disease

• Renal or liver failure

• Expected long fasting periods, >12 hours

• Diabetes Mellitus

• Hypersensitivity to propranolol