Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

Overview[ - collapse ][ - ]

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.
ConditionLaryngeal Papilloma
InterventionDrug: Celebrex
Device: PDL
Procedure: CO2 laser or microsurgery
PhasePhase 2
SponsorBoston University
Responsible PartyBoston University
ClinicalTrials.gov IdentifierNCT00592319
First ReceivedDecember 31, 2007
Last UpdatedAugust 24, 2012
Last verifiedAugust 2012

Tracking Information[ + expand ][ + ]

First Received DateDecember 31, 2007
Last Updated DateAugust 24, 2012
Start DateMay 2005
Estimated Primary Completion DateJuly 2009
Current Primary Outcome MeasuresNumber 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.
Current Secondary Outcome MeasuresTime 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.

Descriptive Information[ + expand ][ + ]

Brief TitleCelebrex (Celecoxib) Treatment of Laryngeal Papilloma
Official TitleVoice-preserving Treatment of Laryngeal Papilloma
Brief 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.
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 TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionLaryngeal Papilloma
InterventionDrug: Celebrex
oral taking of Celebrex (100 mg, BID) for 9 months
Other Names:
CelecoxibDevice: PDL
once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J
Other Names:
585 nm PDL (cynosure Inc. Mass)Procedure: CO2 laser or microsurgery
once-time surgery to remove laryngeal papilloma
Other Names:
ablation laser or micro-instrumental surgery
Study Arm (s)
  • 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
  • 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment10
Estimated Completion DateJuly 2009
Estimated Primary Completion DateJuly 2009
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00592319
Other Study ID NumbersRDC-006617A
Has Data Monitoring CommitteeNo
Information Provided ByBoston University
Study SponsorBoston University
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators Principal Investigator: Wang Zhi, M.D Boston Medical Center
Verification DateAugust 2012

Locations[ + expand ][ + ]

Boston Medical Center
Boston, Massachusetts, United States, 02118