Status:
WITHDRAWN
Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Recurrent Respiratory Papillomatosis
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine if administration of the HPV quadrivalent vaccine in patients diagnosed with RRP has a therapeutic effect on their clinical course. More specifically, does ad...
Detailed Description
Patients who carry the diagnosis of Recurrent Respiratory Papillomatosis (RRP) will be asked to participate in the study. These patients have been followed by the faculty investigator for several year...
Eligibility Criteria
Inclusion
- There are 9 participants currently being followed in the faculty sponsor's clinic that carry the clinical and histologic diagnosis of RRP. The 9 participants meet one or more of the following criteria: Surgery requirement of more than 4 procedures per year, distal multisite spread of disease, and rapid regrowth of papilloma disease with airway compromise.
Exclusion
- If any of the 9 patients meet the following criteria they will be excluded from the study:
- Pregnancy
- Hypersensitivity or allergy to vaccine components (i.e. Saccharomyces cerevisiae yeast)
- Immunocompromised patients (i.e. patients with HIV, cancer, or who take immunosuppressant medications including all forms of steroids)
- Have a fever over 100°F (37.8°C)
- Moderate or severe acute illness (with or without fever)
- Coagulopathies
- Platelet counts of less than 100,000
- Any history of recent treatment(within 3 months) with any investigational drug or other adjuvant RRP therapy (including interferon-gamma, ribavirin, acyclovir, cidofovir and photodynamic therapy, indole-3-carbinol)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00829608
Start Date
January 1 2009
End Date
June 1 2010
Last Update
October 5 2016
Active Locations (1)
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1
University of Missouri
Columbia, Missouri, United States, 65212