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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Papilloma; Recurrent Respiratory Papillomatosis	Drug: SGN-00101	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	27 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
Study Start Date :	November 2001
Study Completion Date :	January 2004

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Arkansas
University of Arkansas for Medical Sciences, Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Florida
Nemour's Childrens Clinic, Division of Pediatric Oncology
Jacksonville, Florida, United States, 32207
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Minnesota
Fairview University Medical Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas, Southwestern Medical School
Dallas, Texas, United States, 75390
United States, Virginia
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Nventa Biopharmaceuticals Corporation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00038714 History of Changes
Other Study ID Numbers:	Stressgen SGN-00101-0005; SGN-00101-0005
First Posted:	June 5, 2002
Last Update Posted:	June 27, 2007
Last Verified:	June 2007

Keywords provided by Nventa Biopharmaceuticals Corporation:

HPV; Papilloma

Additional relevant MeSH terms:

Papilloma; Respiratory Tract Infections; Papillomavirus Infections; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type	Neoplasms; Infection; Respiratory Tract Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections