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

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.