Kidney Cancer Clinical Trial
Official title:
A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to
kill cancer cells. Combining chemotherapy with interleukin-2 and GM-CSF may be a more
effective treatment for kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2, vinblastine,
and GM-CSF in treating patients with metastatic kidney cancer.
OBJECTIVES: I. Determine the effect of sargramostim (granulocyte-macrophage
colony-stimulating factor; GM-CSF) in combination with interleukin-2 and vinblastine on the
response rate of patients with metastatic renal cell carcinoma. II. Assess the potential
toxicities of this treatment combination in these patients.
OUTLINE: This is a single arm, nonrandomized study. Patients receive vinblastine as an IV
bolus once every 2 weeks. Interleukin-2 is administered by subcutaneous injection on days
1-5 each week for 9 weeks. Sargramostim (granulocyte-macrophage colony-stimulating factor;
GM-CSF) is administered by subcutaneous injection on days 1-5 each week for 9 weeks. Each 9
week cycle is followed by 3 weeks of rest. Patient may continue treatment for a maximum of 5
cycles in the absence of disease progression. Patients are assessed every 12 weeks for the
duration of treatment.
PROJECTED ACCRUAL: 20-35 patients will be accrued into this study.
;
Primary Purpose: Treatment
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