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This study has been withdrawn prior to enrollment.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
  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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829608

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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 July 26, 2014