Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis

Inclusion Criteria: Diagnosis of idiopathic pulmonary fibrosis Disease progression despite six months of treatment (steroids with/without azathioprine or cyclophosphamide) defined by at least one of the following: Increased symptoms Decline in forced vital capacity of at least 10% Decline in diffusion capacity for carbon monoxide of at least 20% Increased infiltrate on CXR or high resolution CT scan Taking < 15 mg prednisone for at least 30 days prior to screening Age 35-80, inclusive Able to understand a written informed consent and comply with the study protocol Exclusion Criteria: Significant environmental exposure Diagnosis of collagen vascular disease Evidence of active infection Clinically significant cardiac disease: Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia Poorly controlled or severe diabetes mellitus Pregnancy or lactation Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant) Current enrollment in another experimental protocol Physiologic Criteria: FEV1/FVC < 0.60 Laboratory Criteria: Total bilirubin > 1.5 X upper limit normal AST or ALT > 3X upper limit normal Alkaline phosphatase > 3X upper limit normal White blood cell count < 2,500/mm3 Hematocrit < 30% Platelets < 100,000/mm3 Prothrombin time INR > 1.5