Official Title: “Voice-Preserving Treatment of Laryngeal Papilloma”

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 eventing 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • Celecoxib (100 mg, BID) for 9 months
• Device: pulsed dye laser
  • 585 pulsed dye laser

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • treatment with once-time pulsed dye laser, followed by 9-month oral taking Celebrex, in 15 subjects
• Active Comparator: 2
  • treatment with routine surgery (CO2 laser or "cold" microsurgery), in 15 subjects

Primary Measures

• lesion clearance and recurrence
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• voice improvement and recovery
  • Time Frame: 12 months
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)

Overall Clinical Trial Officials and Contacts

Wang Zhi Principal Investigator Boston Medical Center  

Overall Contact: Gregory Grillone, M.D 617-638-7933 gregory.grillone@bmc.org

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00592319

Study ID Number: RDC-006617A

ClinicalTrials.gov Identifier: NCT00592319

Health Authority: United States: Institutional Review Board