Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

August 24, 2012 updated by: Zhi Wang, Boston University

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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PDL+Celebrex
endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects
Drug: Celebrex
oral taking of Celebrex (100 mg, BID) for 9 months
Other Names:
  • Celecoxib
Device: PDL
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
Other Names:
  • 585 nm PDL (cynosure Inc. Mass)
ACTIVE_COMPARATOR: standard surgery
once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 subjects
Procedure: CO2 laser or microsurgery
once-time surgery to remove laryngeal papilloma
Other Names:
  • ablation laser or micro-instrumental surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Case With Papilloma Recurrence During a 12-month Follow up
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Course (Month) With Papilloma Recurrence During 12-month Follow up
Time Frame: 12 months
The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Wang Zhi, M.D, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (ESTIMATE)

January 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 24, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDC-006617A
  • R01DC006617 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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