Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
|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|
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.|