Celebrex (Celecoxib) Treatment of Laryngeal Papilloma

NCT00592319 | Terminated Phase 2 Results

• 2 other identifiers: RDC-006617AR01DC006617
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Papilloma

Keywords

Papilloma; pulsed dye laser; Celebrex; voice

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time Course (Month) With Papilloma Recurrence During 12-month Follow up

  12 months

Study Arms (2)

PDL+Celebrex

EXPERIMENTAL

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; Device: PDL

standard surgery

ACTIVE COMPARATOR

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

Interventions

Celebrex DRUG

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

Also known as: Celecoxib

PDL+Celebrex

PDL DEVICE

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

Also known as: 585 nm PDL (cynosure Inc. Mass)

PDL+Celebrex

CO2 laser or microsurgery PROCEDURE

once-time surgery to remove laryngeal papilloma

Also known as: ablation laser or micro-instrumental surgery

standard surgery

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 64 years of age
• with laryngeal papillomas requiring surgical treatment
• willingness to participate in the study
• a signed informed consent form

You may not qualify if:

• age less than 18 years
• evidence of mental impairment so that the patient can not understand or sign the consent form
• malignant diseases such as laryngeal cancer
• established coronary heart and artery disorder, cerebrovascular disease, and other cardiovascular diseases
• 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
• hypertension, with ongoing blood pressure \> 150 mg Hg systolic or to require medication
• family history with serious cardiovascular events and problems

Sponsors & Collaborators

• Boston University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Laryngeal papillomatosis; Papilloma

Interventions

Celecoxib; Lasers, Gas; Microsurgery; Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Surgical Procedures, Operative; Micromanipulation; Investigative Techniques; Therapeutics; Ablation Techniques

Limitations and Caveats

We failed to recruit a total of 30 cases, due to (1) This disease is relative less common in clinic; and (2) particularly, more and more of patients now had a serious concern in safety of Celebrex due to news and warnings to public in recent years.

Results Point of Contact

• Title: Dr. Zhi Wang
• Organization: Trustee of Boston Univ. Medical Campus

zwang@bu.edu

617-414-1590

Study Officials

• Wang Zhi, M.D

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 14, 2008
• Study Start: May 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 31, 2012
• Results First Posted: August 24, 2012

Record last verified: 2012-08

Locations

US (1)