GM-CSF in Patients With Pulmonary Alveolar Proteinosis

• Status: Terminated
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).

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

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Molgramostim; Sargramostim

Criteria

Inclusion criteria:

• Diagnosis of primary or idiopathic PAP

• Creatinine no greater than 2 mg/dL

• Bilirubin no greater than 2 mg/dL

• Liver enzymes no greater than 3 times normal

• Women must use an effective method of contraception, be post menopausal, or be surgically sterilized

Exclusion criteria:

• Active respiratory infection

• Active cardiovascular disease (e.g., cardiogenic pulmonary edema)

• Underlying myeloproliferative disorder or leukemia

• Other secondary cause of PAP (e.g., occupational exposure to silica or HIV with PCP)

• At increased risk of side effects from GM-CSF therapy (i.e., rheumatoid arthritis, immune thrombocytopenia, or autoimmune thyroiditis)

• Previous therapy with GM-CSF

• Pregnant or nursing

• Significant renal or liver disease