Clinical trial NCT00592319: Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
Official title: Voice-preserving Treatment of Laryngeal Papilloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Laryngeal Papilloma
Keywords: Papilloma
pulsed dye laser
Celebrex
voice
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2008-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Case With Papilloma Recurrence During a 12-month Follow up
timeFrame: 12-month follow up
Secondary outcomes:
measure: Time Course (Month) With Papilloma Recurrence During 12-month Follow up
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Wang Zhi, M.D
role: PRINCIPAL_INVESTIGATOR
References: