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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Papilloma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Recurrent Respiratory Papillomatosis

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Alabama, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SGN-00101

Drug

Sponsors and collaborators

Lead sponsor

Nventa Biopharmaceuticals Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Study completion: 2004
First posted: Jun 5, 2002
Registry last updated: Jun 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed