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



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

For Condition: Papilloma,Recurrent Respiratory Papillomatosis
Status: Recruiting
Sponsor(s): Stressgen Biotechnologies ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 27

Location and Contact Information:

Fairview University Medical Center, University of Minnesota *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting  

University of Arkansas for Medical Sciences, Arkansas Children's Hospital *Recruiting*
Little Rock,  Arkansas,  72202
United States
Recruiting  

Nemour's Childrens Clinic, Division of Pediatric Oncology *Recruiting*
Jacksonville,  Florida,  32207
United States
Recruiting  

University of Texas, Southwestern Medical School *Recruiting*
Dallas,  Texas,  75390
United States
Recruiting  

University of Iowa Hospitals and Clinics *Recruiting*
Iowa City,  Iowa,  52242
United States
Recruiting  

Children's Hospital of Alabama *Recruiting*
Birmingham,  Alabama,  35233
United States
Recruiting  

University Hospitals of Cleveland *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting  

Children's Hospital of the King's Daughters *Recruiting*
Norfolk,  Virginia,  23507
United States
Recruiting  


Additional Information:
Study ID Numbers:
  Stressgen SGN-00101-0005;  SGN-00101-0005
Study Start Date: November 2001
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038714

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