Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

OBJECTIVES: I. Determine the therapeutic effects of aerosolized sargramostim (GM-CSF) in
terms of progression free survival at 2 months and median survival rate in patients with
metastatic melanoma to the lung. II. Determine the immunomodulatory effects of this
treatment regimen in this patient population. III. Assess the quality of life in terms of
physical and personal concerns of these patients treated with this regimen.

OUTLINE: Patients receive aerosolized sargramostim (GM-CSF) over 10-15 minutes twice daily
for 7 days. Treatment repeats every 2 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to
course 5. Patients are followed every 2 months for at least 1.5 years.

DISEASE CHARACTERISTICS: Histologically confirmed melanoma with radiographic evidence of
prior or active involvement of the lung or pleura Measurable disease At least one lesion
with at least one dimension in diameter of at least 10 mm on CT scan or MRI No
non-measurable disease including the following: Bone lesions Leptomeningeal disease
Ascites Pleural or pericardial effusion Inflammatory breast disease Lymphangitis cutis or
pulmonis Unconfirmed abdominal masses not followed by imaging Cystic lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count
at least 75,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 2
times upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no
greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV
heart disease Other: No uncontrolled infection Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic or
immunotherapy No other concurrent biologic or immunotherapy Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) No concurrent
chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent
systemic glucocorticosteroids Radiotherapy: At least 2 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: Not specified Other: No concurrent immunosuppressants