Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
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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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Laryngeal Papilloma |
Drug: Celebrex Device: PDL Procedure: CO2 laser or microsurgery |
Phase 2 |
| 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 |
- Number of Case With Papilloma Recurrence During a 12-month Follow up [ Time Frame: 12-month follow up ] [ Designated as safety issue: No ]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.
- Time Course (Month) With Papilloma Recurrence During 12-month Follow up [ Time Frame: 12 months ] [ Designated as safety issue: No ]The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.
| 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: PDL+Celebrex
endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects
|
Drug: Celebrex
oral taking of Celebrex (100 mg, BID) for 9 months
Other Name: Celecoxib
Device: PDL
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
Other Name: 585 nm PDL (cynosure Inc. Mass)
|
|
Active Comparator: standard surgery
once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 subjects
|
Procedure: CO2 laser or microsurgery
once-time surgery to remove laryngeal papilloma
Other Name: ablation laser or micro-instrumental surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 64 years of age
- with laryngeal papillomas requiring surgical treatment
- willingness to participate in the study
- a signed informed consent form
Exclusion Criteria:
- 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
Contacts and Locations| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Wang Zhi, M.D | Boston Medical Center |
More Information
No publications provided
| Responsible Party: | Zhi Wang, Professor and Director, Boston University |
| ClinicalTrials.gov Identifier: | NCT00592319 History of Changes |
| Other Study ID Numbers: | RDC-006617A, R01DC006617 |
| Study First Received: | December 31, 2007 |
| Results First Received: | May 3, 2012 |
| Last Updated: | August 24, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration United States: Federal Government |
Keywords provided by Boston University:
|
Papilloma pulsed dye laser Celebrex voice |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013