Use of Cidofovir for Recurrent Respiratory Papillomatosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205374
First received: September 13, 2005
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence.


Condition Intervention Phase
Recurrent Respiratory Papillomatosis
Drug: Cidofovir
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of Cidofovir Injection in the Treatment of Recurrent Respiratory Papillomatosis."

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Reduction in papilloma severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Treatment of RRP with cidofovir injection will be considered efficacious if drug group patients experience clinically or statistically significant reductions in papilloma severity and inter-surgery time intervals (relative to pre-treatment assessments), when compared with placebo group patients.


Secondary Outcome Measures:
  • There are no secondary outcome measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    There are no secondary outcome measures


Enrollment: 19
Study Start Date: November 1999
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cidofovir
On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
Drug: Cidofovir
Subjects will be randomly assigned to either a cidofovir injection or a placebo group, based upon a pre-determined random schedule
Other Name: Vistide
Placebo Comparator: Placebo
On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
Drug: Placebo
On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
Other Name: Sugar pill

Detailed Description:

The focus of the present study is to evaluate the usefulness of cidofovir injection in diminishing the frequency and magnitude of papilloma recurrences in adult and pediatric RRP patients. Briefly, patients will be randomized into either a treatment (cidofovir injection) or a placebo group. The following measures will be made at each of 6 data collection time points, over the course of one year: (1) tumor load, based upon a published staging system for papilloma, (2) degree of respiratory obstruction for phonation, as assessed by phonation threshold pressures, and (3) general health, on validated health inventories (SF12 and Voice Handicap Index for adults; Peds QL for children) and via measures of height weight and days absent from school or daycare, where applicable, for children. A repeated measures analysis will allow examination of time by treatment interactions to determine if the cidofovir injection group has fewer, or less severe, recurrences than the placebo group.

Specifically, we will answer the following questions in this investigation:

  1. Does cidofovir injection reduce the frequency of RRP recurrences?
  2. Does cidofovir injection reduce the magnitude of RRP, as assessed with a proposed staging system for RRP (Derkay et al., 1998) and measures of phonatory threshold pressure?
  3. Does cidofovir injection improve general health, as assessed by height, weight and days absent from school in pediatric patients and health inventories (general health and voice-related) in children and adults?
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 4 surgeries for RRP in last 12 months

Exclusion Criteria:

  • Renal insufficiency
  • Nephrotoxic drugs in the last 7 days
  • Sulfa allergies
  • Currently treated with systemic or topical HPV chemotherapeutic agents
  • Females of childbearing potential with a positive pregnancy test
  • Women who are breast feeding
  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: NCT00205374

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: J. Scott McMurray, MD University of Wisconsin Medical School
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205374     History of Changes
Other Study ID Numbers: 1999-196
Study First Received: September 13, 2005
Last Updated: March 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Papilloma
Papillomavirus Infections
Respiratory Tract Infections
DNA Virus Infections
Infection
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Tumor Virus Infections
Virus Diseases
Cidofovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014