Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Stopped early · Phase 2

Conditions studied: Laryngeal Papilloma

In brief

Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP.

Key facts

Study ID

NCT00592319

Run by

Boston University

People needed

10

Starts

2005-05-01

Expected to finish

2009-07-01

Last updated by the study team

2012-08-31

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 64 years of age
• with laryngeal papillomas requiring surgical treatment
• willingness to participate in the study
• a signed informed consent form

You may not qualify if…

• age less than 18 years
• evidence of mental impairment so that the patient can not understand or sign the consent form
• malignant diseases such as laryngeal cancer
• established coronary heart and artery disorder, cerebrovascular disease, and other cardiovascular diseases
• established diabetes, which requires (1) insulin treatment; or (2) more than 2 oral agents of medication; or (3) to have a baseline HgbA1c >8.0
• hypertension, with ongoing blood pressure > 150 mg Hg systolic or to require medication
• family history with serious cardiovascular events and problems
• any sign and evidence which in the opinion of cardiovascular physician warrants exclusion of subject

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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