Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

NCT01058317 | Withdrawn Phase 2

• 1 other identifier: 09-10-104
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

respiratory, papilloma, pediatric, juvenile

Outcome Measures

Primary Outcomes (1)

• Decreased number of surgeries

  3 months

Secondary Outcomes (1)

• Improved voice quality

  3 months

Study Arms (1)

Children treated with propranolol

EXPERIMENTAL

Drug: Propranolol

Interventions

Propranolol DRUG

Propranolol 2mg/kg divided twice daily

Children treated with propranolol

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma
• \. Child under age 10
• \. Informed consent and where appropriate informed assent
• \. Children who have undergone at least 4 documented surgical interventions in the past year.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

MeSH Terms

Conditions

Recurrent respiratory papillomatosis; Papilloma

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Christopher Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 21, 2013

Record last verified: 2012-04