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

Phase 2
2 Years
18 Years
Not Enrolling
Papilloma, Recurrent Respiratory Papillomatosis

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:

Stressgen SGN-00101-0005



Start Date:

November 2001

Completion Date:

January 2004

Related Keywords:

  • Papilloma
  • Recurrent Respiratory Papillomatosis
  • HPV
  • Papilloma
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections



University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University Hospitals of Cleveland Cleveland, Ohio  44106
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Children's Hospital of Alabama Birmingham, Alabama  35233
University of Arkansas for Medical Sciences, Arkansas Children's Hospital Little Rock, Arkansas  72202
Nemour's Childrens Clinic, Division of Pediatric Oncology Jacksonville, Florida  32207
Fairview University Medical Center, University of Minnesota Minneapolis, Minnesota  55455
University of Texas, Southwestern Medical School Dallas, Texas  75390