Re: Clinical Study in Pediatric Recurrent Respiratory Papillomatosis (RRP)

Re: Clinical Research Study in Pediatric Recurrent Respiratory Papillomatosis (RRP)

A study in children with Recurrent Respiratory Papillomatosis (RRP), sometimes called Juvenile Onset Respiratory Papillomatosis (JORP), is being conducted at approximately 9 medical centers in the United States.

Safety and effectiveness (how well the drug works) of study drug injections given monthly for 3 months will be assessed in treating RRP. Standard surgical care will continue throughout the trial and there will be 12 scheduled clinic visits over 60 weeks. The trial is designed to assess whether treatment with the study drug will delay the next required surgical intervention.

Enrollment for this study is now closed

There are 27 pediatric RRP patients enrolled who met the following eligibility requirements:

Male or female between 2 and 18 years old with documented RRP;
Has had at least 3 prior surgeries for RRP;
Free of life-threatening or serious diseases (other than RRP);
Females must not be pregnant or breast feeding;
Must not have an illness or taking medications that compromise the immune system;
Must not have a history of radiation therapy to the respiratory tract;
Must not receive medicines to treat RRP therapy within 30 days of entry into the study;

ALL INFORMATION WILL BE CONFIDENTIAL AND WILL ONLY BE PROVIDED TO PHYSICIANS AND THEIR STAFF AT THE PARTICIPATING MEDICAL CENTERS WHO ARE RESPONSIBLE FOR THE STUDY.

The medical centers that plan to participate are located in the following cities:

Little Rock, AK
Birmingham, AL
Jacksonville, FL
Iowa City, IA
Cleveland, OH
Minneapolis, MN
Dallas, TX
Norfolk, VA