Clinical Trial: Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Voice-preserving Treatment of Laryngeal Papilloma

Brief Summary: 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.

Detailed Summary: RRP and its surgeries usually involves the vocal cords or other regions of the larynx, thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This technique provides a less traumatic alternative to surgery. However, postoperative recurrence of lesions still remains a problem because of microvascular regrowth. This study is a continuation of our effort to develop a new and less traumatic treatment for RRP. In this study, we will develop a new, combined RRP treatment with PDL and Celebrex. We will determine if Celebrex, a newly developed inhibitor of COX-2, can provide a long-term inhibitory effect on RRP through its anti-angiogenic activity and the synergic effect produced with the laser therapy. The hypothesis is that postoperative administration of Celebrex will provide a long-term inhibitory effect on microvascular regrowth and on COX-2 enzyme, thereby, preventing RRP from recurring after the PDL therapy. Our specific aim in this study is to determine the synergic effect between PDL and Celebrex and long-term efficacy of Celecoxib in preventing postoperative RRP recurrence. We will compare this new combined strategy with traditional treatments in 30 adult patients. This is the first time to combined this new laser MVT technique with a COX-2 inhibitor for microvascular targeting therapy of RRP. 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 and will be safe and convenient enough for use in out-patient treatment.
Sponsor: Boston University

Current Primary Outcome: Number of Case With Papilloma Recurrence During a 12-month Follow up [ Time Frame: 12-month follow up ]

Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.


Original Primary Outcome: lesion clearance and recurrence [ Time Frame: 12 months ]

Current Secondary Outcome: Time Course (Month) With Papilloma Recurrence During 12-month Follow up [ Time Frame: 12 months ]

The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.


Original Secondary Outcome: voice improvement and recovery [ Time Frame: 12 months ]

Information By: Boston University

Dates:
Date Received: December 31, 2007
Date Started: May 2005
Date Completion:
Last Updated: August 24, 2012
Last Verified: August 2012