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Celecoxib Therapy For RRP. Dr. Bettie Steinberg, Dr. Allan Abramson, Dr. Mark Shikowitz LIJ Medical Center Dr. Richard Smith, Dr. Harry Hoffman - Univ. Iowa Dr. Mark Courey – Univ. California, San Francisco Dr. Craig Derkay, Dr. John Sinacori – Eastern Virginia Medical School

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celecoxib therapy for rrp

Celecoxib Therapy For RRP

Dr. Bettie Steinberg, Dr. Allan Abramson, Dr. Mark Shikowitz

LIJ Medical Center

Dr. Richard Smith, Dr. Harry Hoffman - Univ. Iowa

Dr. Mark Courey – Univ. California, San Francisco

Dr. Craig Derkay, Dr. John Sinacori – Eastern Virginia

Medical School

Dr. Glenn Peters, Dr. Paul Castellanos – Univ. Alabama, Birmingham

Dr. Clark Rosen, Univ. Pittsburgh

cyclooxygenase cox 2
Cyclooxygenase (COX-2)
  • Enzyme elevated in inflammation
  • Also elevated in many premalignant and malignant tumors
    • Colorectal polyps
    • Respiratory papillomas
    • Head and neck cancer
    • Breast cancer
    • Lung cancer
    • Cervical cancer
    • Prostate cancer
  • Inhibiting COX-2 helps other types of tumors
cox 2 activities
COX-2 Activities

Arachidonic Acid

COX-2

PGG2

COX-2

PGH2

PGE2

PGD2

PGF2a

PGI2

TXA2

angiogenesis, apoptosis, immune surveillance, differentiation

cox 2 and its product pge 2 are expressed in respiratory papillomas

N

P

N

P

P

Con

COX-2

*

COX-2

300

6

(pg/ml)

*

*

250

Relative COX-2 levels

5

2

Neg

control

200

4

PGE

150

3

Normal

Papilloma

100

2

Normal

Papilloma

50

1

0

0

Papilloma

Normal

COX-2 and Its Product PGE2 Are Expressed in Respiratory Papillomas
inhibiting cox 2 reduces papilloma cell proliferation and increases apoptosis

1.2

*

*

*

*

Normal

6

1.0

*

*

*

*

5

Papilloma

0.8

*

*

4

*

0.6

Relative Apoptosis Levels

3

Relative Proliferation

0.4

2

0.2

1

0.0

0

0

2.5

5.0

7.5

0

2.5

5

7.5

Celecoxib (

µ

M)

Celecoxib (

M)

µ

Inhibiting COX-2 Reduces Papilloma Cell Proliferation and Increases Apoptosis

* p < 0.05

** p < 0.01

three patients treated in pilot study all free of disease

0

3

6

9

12

15

18

21

24

0

0

3

3

6

6

9

9

12

12

15

15

18

18

21

21

24

24

Three Patients Treated in Pilot Study All Free of Disease

Growth Rate

Growth Rate

Months after randomization

Months after randomization

Growth Rate

12 months

18 months

Trachea, Patient 3

Months after randomization

new nih grant to study efficacy of celebrex
New NIH Grant To Study Efficacy of Celebrex
  • 5 year grant
  • Enrolling patients beginning of year
  • Grant will pay for patient travel to one of participating centers
  • Celebrex provided by Pfizer at no cost
  • Grant will permit us to determine whether Celebrex is an effective therapy for RRP, and if some patients respond and others do not, why
eligibility
Eligibility
  • Age 4 years or older
  • 3 or more surgeries in past year or tracheal/ broncheal involvement
  • No history of heart disease or current high blood pressure
  • No significant kidney or liver disease
  • Not allergic to Celebrex or sulfa drugs
clinical celecbrex trial study design

Celebrex

Placebo

Pre Treat

Placebo

Celebrex

Clinical Celecbrex Trial Study Design

Randomize

6 months

12 months

12 months

  • Everyone gets Celebrex
  • Study lasts 30 months for each patient
  • Surgery every 3 months during the study, unless free of disease, then office evaluations every three months
  • Blood tests every three months, at time of surgery, to help determine mechanism of response
if interested in participating
If Interested in Participating

Send patient records to:

Dr. Allan Abramson or Dr. Mark Shikowitz

Department of Otolaryngology

Long Island Jewish Medical Center

270-05 76th Ave

New Hyde Park, NY 11040

Tel: 718-470-7550