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WITHDRAWN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