Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Condition(s) targeted: Recurrent Respiratory Papilloma

Intervention: Celecoxib (Drug); pulsed dye laser (Device)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)

Official(s) and/or principal investigator(s):
Wang Zhi, Principal Investigator, Affiliation: Boston Medical Center

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

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.

Official title: Voice-Preserving Treatment of Laryngeal Papilloma

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

Primary outcome: lesion clearance and recurrence

Secondary outcome: voice improvement and recovery

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 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.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

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

Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Mary Zoccoli, M.D, Phone: 631-398-5652, Email: mary.zoccoli@bmc.org
Gregory Grillone, Sub-Investigator

Starting date: May 2005
Ending date: December 2008
Last updated: August 6, 2008