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

Nventa Biopharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Recurrent Respiratory Papillomatosis

Papilloma

Treatments

Drug: SGN-00101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00038714

Stressgen SGN-00101-0005

SGN-00101-0005

Details and patient eligibility

About

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.

Enrollment

27 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No 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.