Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038714
Recruitment Status : Completed
First Posted : June 5, 2002
Last Update Posted : June 27, 2007
Information provided by:
Nventa Biopharmaceuticals Corporation

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038714

Layout table for location information
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
Layout table for additonal information Identifier: NCT00038714    
Other Study ID Numbers: Stressgen SGN-00101-0005
First Posted: June 5, 2002    Key Record Dates
Last Update Posted: June 27, 2007
Last Verified: June 2007
Keywords provided by Nventa Biopharmaceuticals Corporation:
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections