A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
NCT ID: NCT00038714
Last Updated: 2007-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2001-11-30
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SGN-00101
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
18 Years
ALL
No
Sponsors
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Nventa Biopharmaceuticals Corporation
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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SGN-00101-0005
Identifier Type: -
Identifier Source: secondary_id
Stressgen SGN-00101-0005
Identifier Type: -
Identifier Source: org_study_id