Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
Information source: Boston University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laryngeal Papilloma
Intervention: Celebrex (Drug); PDL (Device); CO2 laser or microsurgery (Procedure)
Phase: Phase 2
Status: Terminated
Sponsored by: Boston University Official(s) and/or principal investigator(s): Wang Zhi, M.D, Principal Investigator, Affiliation: Boston Medical Center
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.
Clinical Details
Official title: Voice-preserving Treatment of Laryngeal Papilloma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Case With Papilloma Recurrence During a 12-month Follow up
Secondary outcome: Time Course (Month) With Papilloma Recurrence During 12-month Follow up
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
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Boston Medical Center, Boston, Massachusetts 02118, United States
Additional Information
Starting date: May 2005
Last updated: August 24, 2012
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