A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma
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
Raj Sadasivan, MD, PhD
Hope Cancer Institute, Inc.
United States: Federal Government
|Bethany Medical Center
|Kansas City, Kansas 66102
|Heartland Cancer Research and Treatment Center
|Kansas City, Kansas 66106