Metastatic Cancer Clinical Trial
Official title:
Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
RATIONALE: Colony-stimulating factors, such as sargramostim, may help the body's immune
system to kill cancer cells. Giving sargramostim in different ways may kill more cancer
cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim given as a breathing
treatment for treating patients who have melanoma that is 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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