Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00003181|
Recruitment Status : Unknown
Verified May 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 30, 2004
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Biological: aldesleukin Biological: sargramostim Drug: vinblastine sulfate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma|
|Study Start Date :||May 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003181
|United States, Kansas|
|Bethany Medical Center|
|Kansas City, Kansas, United States, 66102|
|Heartland Cancer Research and Treatment Center|
|Kansas City, Kansas, United States, 66106|
|Study Chair:||Raj Sadasivan, MD, PhD||Hope Cancer Institute, Inc.|