Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis
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Purpose
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 administration of the vaccine decrease the size and number of papillomas, severity of disease (i.e. hoarseness, inspiratory vs. biphasic stridor, airway obstruction) using the LCAS and time interval between required surgical debulking will be analyzed.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Respiratory Papillomatosis |
Biological: Human Papillomavirus Quadrivalent Vaccine |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigator Initiated Study of Effects of Progression of Recurrent Respiratory Papillomatosis in Patients After They Are Given Human Papillomavirus Quadrivalent Vaccine |
- Comparison of the pre-vaccine and post-vaccine RRP scoring assessments, intersurgical intervals, and annualized surgical rates. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- The secondary end points will include changes in the RRP scoring assessment, intersurgical intervals and changes in annualized surgical rates. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patients diagnosed with RRP
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.
|
Biological: Human Papillomavirus Quadrivalent Vaccine
0.5 mL of quadrivalent HPV vaccine will be given intramuscularly at three separate intervals. Dose 2 is given 2 weeks after dose 1 and dose 3 is given 4 weeks after dose 1 for a total of 3 doses over 2 months.
Other Name: Gardasil, HPV vaccine
|
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 years. Their disease state requires frequent interventions aimed at decreasing the severity and symptomatology of their vocal fold papillomas. Patients will be given the human papillomavirus quadrivalent vaccine and their clinical course will be followed over the next 6 months. Patients will have a laryngoscopic examination prior to treatment to establish their baseline disease state. They will have repeat laryngoscopic examinations at the time of the first, second and third vaccine injections, which will be given 1 month intervals for a total of 3 doses. They will have physical exam and laryngoscopic examinations at 1 month intervals for the first 6 months after administration of the vaccine. The severity of their clinical disease will be objectively measured using a validated scale for RRP assessment, the Laryngoscopic and Clinical Assessment Scale (LCAS).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
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)
Contacts and Locations| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: | Troy D Scheidt, MD | University of Missour-Columbia |
More Information
No publications provided
| Responsible Party: | Troy D. Scheidt, M.D., University of Missouri - Columbia |
| ClinicalTrials.gov Identifier: | NCT00829608 History of Changes |
| Other Study ID Numbers: | 1124197 |
| Study First Received: | January 5, 2009 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Missouri-Columbia:
|
RRP Recurrent Respiratory Papillomatosis HPV vaccine HPV |
Additional relevant MeSH terms:
|
Papilloma Respiratory Tract Infections Papillomavirus Infections Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Infection Respiratory Tract Diseases DNA Virus Infections Virus Diseases Tumor Virus Infections |
ClinicalTrials.gov processed this record on June 18, 2013