Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis

NCT ID: NCT00829608

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-06-30

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 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.

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).

Conditions

Recurrent Respiratory Papillomatosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Papillomavirus Vaccine

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.

Group Type: EXPERIMENTAL

Human Papillomavirus Vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

Human Papillomavirus 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil, HPV vaccine

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Troy D Scheidt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missour-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Other Identifiers

1124197

Identifier Type: -

Identifier Source: org_study_id