PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Metastatic disease Measurable disease Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI Histologic confirmation required if measurable disease is confined to a solitary lesion The following are not considered measurable disease: Bone disease only Pleural or peritoneal metastases CNS lesions Irradiated lesions unless disease progression was documented after prior radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL No decompensated liver disease Renal Creatinine ≤ 2.0 mg/dL Immunologic No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system No history of autoimmune disease No autoimmune hepatitis No immunosuppressed transplantation recipients Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range No severe psychiatric condition or disorder, including suicidal ideation or attempt No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy Surgery Not specified
Sites / Locations
- Hollings Cancer Center at Medical University of South Carolina
Arms of the Study
Arm 1
Experimental
PEG-Intron, BM-CSF and thalidomide