Kidney Cancer Clinical Trial
Official title:
A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
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.
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