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

This study has been completed.

First Received on June 4, 2002. Last Updated on June 26, 2007 History of Changes

Sponsor:	Nventa Biopharmaceuticals Corporation
Information provided by:	Nventa Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00038714

Purpose

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	Intervention	Phase
Papilloma Recurrent Respiratory Papillomatosis	Drug: SGN-00101	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis

Further study details as provided by Nventa Biopharmaceuticals Corporation:

Estimated Enrollment:	27
Study Start Date:	November 2001
Estimated Study Completion Date:	January 2004

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038714

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00038714 History of Changes
Other Study ID Numbers:	Stressgen SGN-00101-0005, SGN-00101-0005
Study First Received:	June 4, 2002
Last Updated:	June 26, 2007
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 09, 2012