Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

NCT ID: NCT01058317

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-09-30

Brief 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.

Conditions

Recurrent Respiratory Papillomatosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Children treated with propranolol

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Propranolol 2mg/kg divided twice daily

Interventions

Propranolol

Propranolol 2mg/kg divided twice daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Hartnick, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Other Identifiers

09-10-104

Identifier Type: -

Identifier Source: org_study_id