Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Summary
This is a randomized double blind controlled study to determine if celebrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric patients with recurrent respiratory papillomatosis. All patients will be evaluated for disease severity at enrollment and at 3 month intervals for 30 months. After randomization, patients in the early treatment arm will begin celecoxib 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will receive celecoxib for 1 year. During the time that patients do no receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits will occur at three month intervals for the duration of the study.
Description
This is a randomized double blind placebo-controlled study,with plans to include 5 additional U.S. centers in the near future. The primary goal of this study is to determine whether celecoxib has efficacy in elimination or reduction of recurrent disease in patients with RRP. Our secondary goals are to determine whether continued celecoxib is required to maintain response, to correlate response with select patient demographics and persistence of latent HPV DNA, and to determine whether celecoxib is acting through inhibition of COX-2, in order to begin to determine mechanism of effects in vivo on RRP. The study design encompasses a 30-month period, which can be divided into three segments:
Segment A: This is a 6 month run-in period in which all patients are assessed by direct laryngoscopy/bronchoscopy for disease severity, to permit growth rate stabilization and confirm accuracy of training of participating physicians. Patients will be treated by conventional surgery at three months and six months after enrollment.
Segment B: Patients begin 12 months of 400mg(adults), 100 mg (pediatric weight between 12 and 25 kg)or 200 mg (pediatric weight > 25kg) celecoxib daily or placebo treatment in addition to surgical removal of all papillomas at each 3 month interval. This segment directly tests the hypothesis that celecoxib is an efficacious treatment for moderate to severe RRP and forms the basis for the primary statistical analyses.
Segment C: The primary purpose of this segment is to determine whether gains made during celecoxib therapy are maintained after it is discontinued, or whether celecoxib will need to be taken indefinitely. This will be determined by a 12 month period on placebo after cessation of celecoxib for the early treatment group.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Recurrent Respiratory Papillomatosis
Intervention
celebrex (celecoxib), placebo capsules
Location
University of Alabama Birmingham
Birmingham
Alabama
United States
35294
Status
Active, not recruiting
Source
North Shore Long Island Jewish Health System
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00571701
- Information obtained from ClinicalTrials.gov on December 16, 2012
Medical and Biotech [MESH] Definitions
Human Papillomavirus 11
A type of ALPHAPAPILLOMAVIRUS causing recurrent respiratory PAPILLOMATOSIS; GENITAL WARTS; and other neoplasms.
Bacterial Capsules
An envelope of loose gel surrounding a bacterial cell which is associated with the virulence of pathogenic bacteria. Some capsules have a well-defined border, whereas others form a slime layer that trails off into the medium. Most capsules consist of relatively simple polysaccharides but there are some bacteria whose capsules are made of polypeptides.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Sleep Apnea, Obstructive
A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395)
Porcine Respiratory Coronavirus
A mutant strain of TRANSMISSIBLE GASTROENTERITIS VIRUS causing mild or subclinical respiratory infections in young SWINE. It may also play a role in post-weaning porcine respiratory disease complex, especially when combined with other respiratory agents.
Clinical Trials
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PubMed Articles
Recurrent Respiratory Papillomatosis Arising in Trachea not Affecting Larynx.
Recurrent respiratory papillomatosis (RRP) is an infrequent benign neoplasm commonly involving the upper respiratory tract with laryngeal predilection. The diagnosis and treatment of this disease are...
Treatment of recurrent respiratory papillomatosis lung involvement by cidofovir infusion.
Abstract Lung parenchyma involvement in recurrent respiratory papillomatosis (RRP) is rare, can be severe, and has variable outcomes. Although several reports have described the effects of different d...
Celecoxib (Celebrex®) was the first cyclo-oxygenase (COX)-2 selective inhibitor (coxib) to be introduced into clinical practice. Coxibs were developed to provide anti-inflammatory/analgesic activity...
Objective: Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). Methods: Analysis of randomized controlled trials from the Pfizer clini...
Sudden death and laryngeal papillomatosis: A case report.
Laryngeal papillomatosis is an uncommon respiratory disease. Often misdiagnosed, it can cause acute respiratory insufficiency, quickly fatal if not promptly faced. A case of sudden death due to laryng...
