Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

This study has been terminated.
(03/01/2009,due to date close to termination of this funding/study period)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Zhi Wang, Boston University
ClinicalTrials.gov Identifier:
NCT00592319
First received: December 31, 2007
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Laryngeal Papilloma
Drug: Celebrex
Device: PDL
Procedure: CO2 laser or microsurgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Voice-preserving Treatment of Laryngeal Papilloma

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Number of Case With Papilloma Recurrence During a 12-month Follow up [ Time Frame: 12-month follow up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time Course (Month) With Papilloma Recurrence During 12-month Follow up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.


Enrollment: 10
Study Start Date: May 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Celecoxib
Device: PDL
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
Other Name: 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 Name: ablation laser or micro-instrumental surgery

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592319

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Wang Zhi, M.D Boston Medical Center
  More Information

No publications provided

Responsible Party: Zhi Wang, Professor and Director, Boston University
ClinicalTrials.gov Identifier: NCT00592319     History of Changes
Other Study ID Numbers: RDC-006617A, R01DC006617
Study First Received: December 31, 2007
Results First Received: May 3, 2012
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Boston University:
Papilloma
pulsed dye laser
Celebrex
voice

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014