RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
OBJECTIVES: Primary * Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma. Secondary * Determine duration of response in patients treated with this regimen. * Determine the tolerance to and toxicity of this regimen in these patients. * Determine the median and progression-free survival of patients treated with this regimen. OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
200mg daily by mouth
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Response Rate
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Time frame: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
Duration of Response
Time frame: time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Frequency of Adverse Events Assessed by NCI CTC Version 2
Time frame: From the first day of treatment until the end of treatment visit, an average of 6 months
Progression-free Survival
Time frame: From registration until diease progression or death, whichever comes first.
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