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Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis

This study has been withdrawn prior to enrollment.
(investigator has left the institution)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00829608
First received: January 5, 2009
Last updated: January 24, 2013
Last verified: January 2013

January 5, 2009
January 24, 2013
January 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00829608 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis
Investigator Initiated Study of Effects of Progression of Recurrent Respiratory Papillomatosis in Patients After They Are Given Human Papillomavirus Quadrivalent Vaccine

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.

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).

Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Respiratory Papillomatosis
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
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.
Intervention: Biological: Human Papillomavirus Quadrivalent Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2010
December 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829608
1124197
No
Troy D. Scheidt, M.D., University of Missouri - Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Troy D Scheidt, MD University of Missour-Columbia
University of Missouri-Columbia
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP