A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
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| ClinicalTrials.gov Identifier: NCT00038714 |
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Recruitment Status :
Completed
First Posted : June 5, 2002
Last Update Posted : June 27, 2007
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Sponsor:
Nventa Biopharmaceuticals Corporation
Information provided by:
Nventa Biopharmaceuticals Corporation
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Papilloma Recurrent Respiratory Papillomatosis | Drug: SGN-00101 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 27 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis |
| Study Start Date : | November 2001 |
| Study Completion Date : | January 2004 |
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| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038714
Locations
| United States, Alabama | |
| Children's Hospital of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences, Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, Florida | |
| Nemour's Childrens Clinic, Division of Pediatric Oncology | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Minnesota | |
| Fairview University Medical Center, University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| University of Texas, Southwestern Medical School | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
Nventa Biopharmaceuticals Corporation
| ClinicalTrials.gov Identifier: | NCT00038714 |
| Other Study ID Numbers: |
Stressgen SGN-00101-0005 SGN-00101-0005 |
| First Posted: | June 5, 2002 Key Record Dates |
| Last Update Posted: | June 27, 2007 |
| Last Verified: | June 2007 |
Keywords provided by Nventa Biopharmaceuticals Corporation:
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HPV Papilloma |
Additional relevant MeSH terms:
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Respiratory Tract Infections Papillomavirus Infections Papilloma Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Infection Respiratory Tract Diseases DNA Virus Infections Virus Diseases Tumor Virus Infections |