Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003181
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Interleukin-2 Vinblastine and GM-CSF in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Hope Cancer Institute Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Using Low Dose Subcutaneous IL-2 Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2001-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1373 | None | None | None |
| HCRN-002 | None | None | None |