A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis

Completed · Phase 2

Conditions studied: Papilloma, Recurrent Respiratory Papillomatosis

In brief

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.

Key facts

Study ID

NCT00038714

Run by

Nventa Biopharmaceuticals Corporation

People needed

27

Starts

2001-11-01

Expected to finish

2004-01-01

Last updated by the study team

2007-06-27

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 2 and 18 yrs old, inclusive, who has documented RRP.
• Patients with documented RRP
• Subject is surgically debulked within 7 days before the first dose of SGN-00101.
• Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries.
• Subject is free of life threatening or serious concomitant disorders other than the disease under study.
• Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator.

You may not qualify if…

• Subject has disease or status that causes compromise of the immune system.
• Subject has a history of ionizing radiation therapy to the respiratory tract.
• Patient has used concomitant medications that may suppress the immune system.
• Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study.
• Subject has participated in a past study with SGN-00101
• Pregnancy and lactation.

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences, Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Nemour's Childrens Clinic, Division of Pediatric Oncology — Jacksonville, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Fairview University Medical Center, University of Minnesota — Minneapolis, Minnesota, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• University of Texas, Southwestern Medical School — Dallas, Texas, United States
• Children's Hospital of the King's Daughters — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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