Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00205374

Use of Cidofovir for Recurrent Respiratory Papillomatosis

Recurrent Respiratory Papillomatosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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; PedsQL (Trademarked) 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? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00205374
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Completed
Phase Phase 4
Start date November 1999
Completion date December 2009
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02854761 - Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP) Phase 1
Terminated NCT00747461 - Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD") Phase 4
Completed NCT01020747 - Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP) Phase 1
Completed NCT00038714 - A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis Phase 2
Active, not recruiting NCT04724980 - Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis Phase 1/Phase 2
Not yet recruiting NCT04645602 - Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement Phase 2
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Withdrawn NCT01058317 - Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis Phase 2/Phase 3
Withdrawn NCT00829608 - Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis Phase 0
Completed NCT00550914 - Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP N/A
Not yet recruiting NCT01995721 - 4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children Phase 3
Completed NCT02217358 - Value of Narrow Band Imaging (NBI) Endoscopy in the Early Diagnosis of Laryngeal Cancer and Precancerous Lesions N/A
Completed NCT00571701 - Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis Phase 2
Recruiting NCT02555800 - Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis Phase 2
Completed NCT03707587 - M7824 in People With Recurrent Respiratory Papillomatosis Phase 2
Completed NCT02859454 - Avelumab for People With Recurrent Respiratory Papillomatosis Phase 2
Active, not recruiting NCT02632344 - Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients Phase 2
Completed NCT02592902 - Recurrent Respiratory Papillomatosis and Extraesophageal Reflux N/A
Recruiting NCT06412172 - The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
Recruiting NCT03465280 - Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)