Use of Cidofovir for Recurrent Respiratory Papillomatosis - Full Text View

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:

Drug Information available for: Cidofovir

U.S. FDA Resources

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:

Does cidofovir injection reduce the frequency of RRP recurrences?
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?
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

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
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
Cidofovir
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on June 17, 2013