Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00003181
- Lead Sponsor
- Hope Cancer Institute, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Bethany Medical Center
🇺🇸Kansas City, Kansas, United States
Heartland Cancer Research and Treatment Center
🇺🇸Kansas City, Kansas, United States
Bethany Medical Center🇺🇸Kansas City, Kansas, United States