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| Sponsor: | Boston University |
|---|---|
| Collaborator: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Information provided by: | Boston University |
| ClinicalTrials.gov Identifier: | NCT00592319 |
Purpose
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 Celecoxib. We will determine if Celecoxib, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Papilloma of the Larynx |
Drug: Celecoxib Device: pulsed dye laser Procedure: CO2 laser or microsurgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Voice-preserving Treatment of Laryngeal Papilloma |
| Enrollment: | 10 |
| Study Start Date: | May 2005 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
treatment with once-time pulsed dye laser, followed by 9-month oral taking Celebrex, in 15 subjects
|
Drug: Celecoxib
Celecoxib (100 mg, BID) for 9 months
Device: pulsed dye laser
585 pulsed dye laser
Other Name: made by cynosure Inc. Mass
|
|
Active Comparator: 2
treatment with routine surgery (CO2 laser or "cold" microsurgery), in 15 subjects
|
Procedure: CO2 laser or microsurgery
once procedure
Other Name: routine CO2 laser or micro-instrumental surgery
|
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 pulsed dye laser (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 Celecoxib. We will determine if Celecoxib, a newly developed inhibitor of cyclooxygenase (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 Celecoxib 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 Celecoxib 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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Zhi Wang, Trustees of Boston University |
| ClinicalTrials.gov Identifier: | NCT00592319 History of Changes |
| Other Study ID Numbers: | RDC-006617A, R01DC006617, R01-006617-2 |
| Study First Received: | December 31, 2007 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration; United States: Federal Government |
|
Papilloma pulsed dye laser Celecoxib voice |
|
Papilloma Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |