Aerosolized GM-CSF in the Treatment of Metastatic Melanoma 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.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 7-17
months.
Interventional
Primary Purpose: Treatment
Svetomir Markovic, MD, PhD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067739
NCT00005610
September 2000
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |
Illinois Oncology Research Association | Peoria, Illinois 61602 |