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.