Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
Kidney Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, lung metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma for which no known standard therapy that is potentially curative or capable of extending life expectancy exists (e.g., surgery) Measurable metastatic disease in the lung At least one unidimensionally measurable lesion at least 20 mm by conventional techniques No CNS metastases that require treatment 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/mm^3 Platelet count at least 75,000/mm^3 Hemoglobin greater than 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 Pulmonary No hemoptysis of grade 3 or greater No reactive airway disease on active therapy Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection No other metastatic malignancy within the past 3 years except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy More than 2 weeks since prior immunotherapy More than 2 weeks since other prior biologic therapy Chemotherapy More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy More than 2 weeks since prior corticosteroids No concurrent systemic glucocorticoids Radiotherapy More than 2 weeks since prior radiotherapy No prior radiotherapy to more than 10% of total lung volume in the radiation field Other At least 4 weeks since prior bronchodialators No concurrent immunosuppressive agents
Sites / Locations
- CCOP - Scottsdale Oncology Program
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Ann Arbor Regional
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Quain & Ramstad Clinic, P.C.
- CCOP - Merit Care Hospital
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinic and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Central Plains Clinic, Ltd.
- Saskatchewan Cancer Agency
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Experimental
aerosolized sargramostim
Patients receive aerosolized sargramostim (GM-CSF) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity. Patients are followed for disease progression and then every 3 months thereafter.