Clinical trial NCT00038714: A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
Official title: A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Papilloma
Recurrent Respiratory Papillomatosis
Keywords: HPV
Papilloma
Lead sponsor: Nventa Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2002-06-05
Enrollment: 27
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences, Arkansas Children's Hospital
state: Arkansas
city: Jacksonville
country: United States
facility: Nemour's Childrens Clinic, Division of Pediatric Oncology
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Minneapolis
country: United States
facility: Fairview University Medical Center, University of Minnesota
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical School
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
Study officials:
References: