Overview

Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Status:
Terminated

Trial end date:
2009-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boston University

Collaborator:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Treatments:

Celecoxib

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