PapillomaPhase 2NCT00038714
A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
A Phase 2 study testing SGN-00101 in people with Papilloma and Recurrent Respiratory Papillomatosis, run by Nventa Biopharmaceuticals Corporation at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Papilloma, Recurrent Respiratory Papillomatosis
- What is being tested?
- SGN-00101
- How many people
- 27 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2001to Jan 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Hospital of Alabama
Birmingham, Alabama, 35233
University Hospitals of Cleveland
Cleveland, Ohio, 44106
University of Texas, Southwestern Medical School
Dallas, Texas, 75390
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Nemour's Childrens Clinic, Division of Pediatric Oncology
Jacksonville, Florida, 32207
University of Arkansas for Medical Sciences, Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Fairview University Medical Center, University of Minnesota
Minneapolis, Minnesota, 55455
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
About this study
Official title: A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
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.
- Conditions
- Papilloma, Recurrent Respiratory Papillomatosis
- Being tested
- SGN-00101
- Keywords
- HPV, Papilloma
- Medical subject headings
- Papilloma, Recurrent respiratory papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-00101Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2002 (estimated)
- Study startNov 2001
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PapillomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nventa Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038714
- Sponsor's protocol ID
- Stressgen SGN-00101-0005
- Other IDs
- SGN-00101-0005
- Status last verified
- Jun 2007
- First submitted
- 4 Jun 2002
- Last updated
- 27 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
- ClinicalTrials.gov ID
- NCT00038714
- Acronym / sponsor ID
- Stressgen SGN-00101-0005
- Conditions
- Papilloma, Recurrent Respiratory Papillomatosis
- Keywords
- HPV, Papilloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Nventa Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Jan 2004
- First posted
- 5 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGN-00101 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGN-00101 in people with Papilloma and Recurrent Respiratory Papillomatosis, run by Nventa Biopharmaceuticals Corporation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2007.