GM-CSF in Patients With Pulmonary Alveolar Proteinosis

Stopped early · Phase 2

Conditions studied: Pulmonary Alveolar Proteinosis

In brief

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).

Key facts

Study ID

NCT00030056

Run by

The Cleveland Clinic

People needed

48

Starts

2001-09-01

Expected to finish

2005-12-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Jewish Medical Center — Denver, Colorado, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.