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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

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Celecoxib Therapy For RRP

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  1. 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

  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

  3. COX-2 Activities Arachidonic Acid COX-2 PGG2 COX-2 PGH2 PGE2 PGD2 PGF2a PGI2 TXA2 angiogenesis, apoptosis, immune surveillance, differentiation

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

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