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

Recurrent Respiratory Papillomatosis Clinical Trial

Official title:

A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038714
• Other study ID #: Stressgen SGN-00101-0005
• Secondary ID: SGN-00101-0005
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2002
• Last updated: June 26, 2007
• Start date: November 2001
• Est. completion date: January 2004

Study information

• Verified date: June 2007
• Source: Nventa Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Intervention

Drug:
• SGN-00101

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nventa Biopharmaceuticals Corporation

Country where clinical trial is conducted

United States,