NCT00592319

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Voice-preserving Treatment of Laryngeal Papilloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Laryngeal Papilloma

Interventions

Type	Name	Description
DRUG	Celebrex	oral taking of Celebrex (100 mg, BID) for 9 months
DEVICE	PDL	once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
PROCEDURE	CO2 laser or microsurgery	once-time surgery to remove laryngeal papilloma

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-01-14
• Last updated: 2012-08-31
• Results posted: 2012-08-24

Locations

1 site across 1 country: United States