Loading clinical trials...

A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00038714•Nventa Biopharmaceuticals Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

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.

Locations (8)

Children's Hospital of Alabama

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences, Arkansas Children's Hospital

Little Rock, Arkansas, United States

Nemour's Childrens Clinic, Division of Pediatric Oncology

Jacksonville, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Fairview University Medical Center, University of Minnesota

Minneapolis, Minnesota, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

University of Texas, Southwestern Medical School

Dallas, Texas, United States

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Key Dates

Start Date

November 1, 2001

Completion Date

January 1, 2004

Last Updated

June 27, 2007

Enrollment

ESTIMATED participants

Conditions

PapillomaRecurrent Respiratory Papillomatosis

Interventions

SGN-00101

DRUG

Stories to Prevent (StoP) HPV Cancers

NCT06808776

Human Papillomavirus VaccinationEmotions

View study

RECRUITING

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study

NCT06115772

Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Stories to Prevent (StoP) HPV Cancers

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV