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

Sponsor

Nventa Biopharmaceuticals Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00038714

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Papilloma Recurrent Respiratory Papillomatosis	Drug: SGN-00101	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2001

Study Completion Date :

Jan 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama	Birmingham	Alabama	United States	35233
2	University of Arkansas for Medical Sciences, Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
3	Nemour's Childrens Clinic, Division of Pediatric Oncology	Jacksonville	Florida	United States	32207
4	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
5	Fairview University Medical Center, University of Minnesota	Minneapolis	Minnesota	United States	55455
6	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
7	University of Texas, Southwestern Medical School	Dallas	Texas	United States	75390
8	Children's Hospital of the King's Daughters	Norfolk	Virginia	United States	23507