A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
2 other identifiers
interventional
27
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2001
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 4, 2002
CompletedFirst Posted
Study publicly available on registry
June 5, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedJune 27, 2007
June 1, 2007
June 4, 2002
June 26, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences, Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Nemour's Childrens Clinic, Division of Pediatric Oncology
Jacksonville, Florida, 32207, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Fairview University Medical Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
University of Texas, Southwestern Medical School
Dallas, Texas, 75390, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2002
First Posted
June 5, 2002
Study Start
November 1, 2001
Study Completion
January 1, 2004
Last Updated
June 27, 2007
Record last verified: 2007-06