Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized double blind controlled study to determine if celebrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric patients with recurrent respiratory papillomatosis. All patients will be evaluated for disease severity at enrollment and at 3 month intervals for 30 months. After randomization, patients in the early treatment arm will begin celecoxib 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits will occur at three month intervals for the duration of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborators: Eastern Virginia Medical School; National Institute on Deafness and Other Communication Disorders (NIDCD); Sanford Health; University of Alabama at Birmingham; University of California, San Francisco; University of Iowa; Vanderbilt University; Weill Medical College of Cornell University
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Moderate to severe disease, defined as:

Patients who have rapid regrowth of papillomas, requiring endoscopic removal at least 3 times within the past 12 months AND A papilloma growth rate from 0.03 to 0.06 (moderate) or >0.06 (severe) at time of initial direct endoscopy OR Having tracheal and/or bronchial or pulmonary papillomatosis (severe)

• Age > 2 years

• Gender- no restriction

• Race- no restriction

Exclusion Criteria:

• Fewer than 3 surgical procedures in previous year, without tracheal disease

• Age < 2 years

• Pregnancy, trying to become pregnant, breastfeeding or not willing to comply with birth control methods if sexually active female

• Serum creatinine > 1.5 X normal

• History of documented peptic ulcer disease or gastritis persisting despite treatment

• Abnormal liver function tests, as total bilirubin >1.5 X normal and SGOT > 3 X normal

• Allergy to NSAIDs, sulfa containing drugs or symptoms of Stevens-Johnson Syndrome

• Patients with connective tissue diseases such as SLE, Raynaud's or Systemic Sclerosis

• Patients with known diabetes

• Patients on warfarin, or on loop or thiazide diuretics

• Patients with a history of cardiovascular disease, myocardial infarct or stroke

• Patients with congestive heart failure

• Patients regularly taking > 81 mg of aspirin/day

• Patients with uncontrolled hypertension

• Patients with RRP associated malignancy currently receiving chemotherapy and/or radiation