Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
Overview[ - collapse ][ - ]
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 | Laryngeal Papilloma |
Intervention | Drug: Celebrex Device: PDL Procedure: CO2 laser or microsurgery |
Phase | Phase 2 |
Sponsor | Boston University |
Responsible Party | Boston University |
ClinicalTrials.gov Identifier | NCT00592319 |
First Received | December 31, 2007 |
Last Updated | August 24, 2012 |
Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 31, 2007 |
---|---|
Last Updated Date | August 24, 2012 |
Start Date | May 2005 |
Estimated Primary Completion Date | July 2009 |
Current Primary Outcome Measures | 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. |
Current Secondary Outcome Measures | 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. |
Descriptive Information[ + expand ][ + ]
Brief Title | Celebrex (Celecoxib) Treatment of Laryngeal Papilloma |
---|---|
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 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. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Laryngeal Papilloma |
Intervention | Drug: Celebrex oral taking of Celebrex (100 mg, BID) for 9 months Other Names: CelecoxibDevice: PDL once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J Other Names: 585 nm PDL (cynosure Inc. Mass)Procedure: CO2 laser or microsurgery once-time surgery to remove laryngeal papilloma Other Names: ablation laser or micro-instrumental surgery |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
---|---|
Estimated Enrollment | 10 |
Estimated Completion Date | July 2009 |
Estimated Primary Completion Date | July 2009 |
Eligibility Criteria | Inclusion Criteria: 1. 18 to 64 years of age 2. with laryngeal papillomas requiring surgical treatment 3. willingness to participate in the study 4. a signed informed consent form Exclusion Criteria: 1. age less than 18 years 2. evidence of mental impairment so that the patient can not understand or sign the consent form 3. malignant diseases such as laryngeal cancer 4. established coronary heart and artery disorder, cerebrovascular disease, and other cardiovascular diseases 5. 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 6. hypertension, with ongoing blood pressure > 150 mg Hg systolic or to require medication 7. family history with serious cardiovascular events and problems 8. any sign and evidence which in the opinion of cardiovascular physician warrants exclusion of subject |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00592319 |
---|---|
Other Study ID Numbers | RDC-006617A |
Has Data Monitoring Committee | No |
Information Provided By | Boston University |
Study Sponsor | Boston University |
Collaborators | National Institute on Deafness and Other Communication Disorders (NIDCD) |
Investigators | Principal Investigator: Wang Zhi, M.D Boston Medical Center |
Verification Date | August 2012 |
Locations[ + expand ][ + ]
Boston Medical Center | Boston, Massachusetts, United States, 02118 |
---|