Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Laryngeal Papilloma Clinical Trial

Official title:

Voice-preserving Treatment of Laryngeal Papilloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00592319
• Other study ID #: RDC-006617A
• Secondary ID: R01DC006617
• Status: Terminated
• Phase: Phase 2
• First received: December 31, 2007
• Last updated: August 24, 2012
• Start date: May 2005
• Est. completion date: July 2009

Study information

• Verified date: August 2012
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngeal Papilloma
• Papilloma

Intervention

Drug:
• Celebrex
oral taking of Celebrex (100 mg, BID) for 9 months

Device:
• PDL
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J

Procedure:
• CO2 laser or microsurgery
once-time surgery to remove laryngeal papilloma

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Case With Papilloma Recurrence During a 12-month Follow up	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.	12-month follow up	No
Secondary	Time Course (Month) With Papilloma Recurrence During 12-month Follow up	The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.	12 months	No