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Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
This study is ongoing, but not recruiting participants.
First Received: December 31, 2007   Last Updated: July 24, 2009   History of Changes
Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT00592319
  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 Celecoxib. We will determine if Celecoxib, 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: Celecoxib
Device: pulsed dye laser
Procedure: CO2 laser or microsurgery
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title: Voice-preserving Treatment of Laryngeal Papilloma

Resource links provided by NLM:


Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:
  • lesion clearance and recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • voice improvement and recovery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
treatment with once-time pulsed dye laser, followed by 9-month oral taking Celebrex, in 15 subjects
Drug: Celecoxib
Celecoxib (100 mg, BID) for 9 months
Device: pulsed dye laser
585 pulsed dye laser
2: Active Comparator
treatment with routine surgery (CO2 laser or "cold" microsurgery), in 15 subjects
Procedure: CO2 laser or microsurgery
once procedure

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 pulsed dye laser (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 Celecoxib. We will determine if Celecoxib, a newly developed inhibitor of cyclooxygenase (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 Celecoxib 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 Celecoxib 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592319

Sponsors and Collaborators
Investigators
Principal Investigator: Wang Zhi Boston Medical Center
  More Information

No publications provided

Responsible Party: Trustees of Boston University ( Zhi Wang )
Study ID Numbers: RDC-006617A, R01-006617-2
Study First Received: December 31, 2007
Last Updated: July 24, 2009
ClinicalTrials.gov Identifier: NCT00592319     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration;   United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Papilloma
pulsed dye laser
Celecoxib
voice

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

ClinicalTrials.gov processed this record on February 04, 2010