Clinical Trial: Use of Cidofovir for Recurrent Respiratory Papillomatosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Cidofovir Injection in the Treatment of Recurrent Respiratory Papillomatosis."

Brief Summary: 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.

Detailed Summary:

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?

Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Reduction in papilloma severity [ Time Frame: 1 year ]

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.


Original Primary Outcome:

Current Secondary Outcome: There are no secondary outcome measures [ Time Frame: 1 year ]

There are no secondary outcome measures


Original Secondary Outcome:

Information By: University of Wisconsin, Madison

Dates:
Date Received: September 13, 2005
Date Started: November 1999
Date Completion:
Last Updated: March 30, 2012
Last Verified: March 2012