Emory University researchers are recruiting patients to participate in a multi-center study to test an investigational treatment for Idiopathic Pulmonary Fibrosis (IPF), a chronic lung disease that progressively steals the ability to breathe from its victims.
The phase two trial is a randomized, double-blind placebo-controlled study of the safety and clinical effects of Gleevec (imatinib mesylate) in patients who have not responded to standard IPF therapy. The drug will be administered orally to patients diagnosed with IPF.
Gleevec (manufactured by Novartis, Inc.) is a signal transduction inhibitor. The class of drugs is used to prevent cancer cells from rapidly multiplying and invading other tissues. It also inhibits lung fibroblasts which promote fibrosis in the lungs. Gleevec is already approved for the treatment of gastrointestinal stromal tumors and chronic myeloid leukemia.
A total of 100 patients are needed for the entire multi-center study. Patients recruited through Emory University will be enrolled at the Veteran Affairs Medical Center. Of the total 100 patients who will be enrolled in the trial for a period of up to two years, 50 participants will be treated initially with 600 mg of Gleevec orally once per day versus, 50 who will receive a placebo (an inactive substance that contains no medication).
Male and female study patients, ages 20-79, with clinical symptoms consistent with IPF and onset between three months and 36 months prior to screening are being considered. They also must be free of other clinical signs that suggest infection, cancer, sarcoidosis, collagen vascular disease, or exposure to known fibrogenic environmental factors. Additional eligibility criteria and more information can be obtained by calling Patricia Alvarez, MD at (404) 727-6821.
IPF is classified as an interstitial lung disease, a group of lung conditions that is characterized by a build up of scar tissue in the lungs. The disease damages the air sacs of the lower respiratory tract as the scar tissue forms and thickens, causing an irreversible reduction of the transfer of oxygen to the bloodstream.
No definite cause for IPF has been discovered, and other tested treatments have shown evidence of suppressing inflammation but little success in reducing the fibrotic progress.
According to the Coalition for Pulmonary Fibrosis, an estimated 31,000 new cases of Idiopathic Pulmonary Fibrosis are diagnosed each year and approximately 83,000 Americans suffer from IPF. An estimated two-thirds of those patients die within five years of diagnosis.