Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018941
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2001-07-11
Brief Title:
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Intravenous Low Dose Versus Intravenous High Dose Versus Subcutaneous Interleukin-2 for Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells It is not yet known which regimen of interleukin-2 is most effective for kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES I Determine the response rate and overall survival of patients with metastatic renal cell carcinoma treated with either low-dose or high-dose intravenous interleukin-2 IL-2 or subcutaneous IL-2 II Compare the toxic effects of these 3 regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to presence of renal tumor yes vs no Patients are randomized to one of three treatment arms Arm I Patients receive low dose interleukin-2 IL-2 IV every 8 hours for up to 15 doses Treatment repeats in 7-10 days for one complete course Arm II Patients receive high dose IL-2 IV every 8 hours for up to 15 doses Treatment repeats in 7-10 days for one complete course Arm III Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease receive an additional complete course of therapy
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
OUTLINE This is a randomized study Patients are stratified according to presence of renal tumor yes vs no Patients are randomized to one of three treatment arms Arm I Patients receive low dose interleukin-2 IL-2 IV every 8 hours for up to 15 doses Treatment repeats in 7-10 days for one complete course Arm II Patients receive high dose IL-2 IV every 8 hours for up to 15 doses Treatment repeats in 7-10 days for one complete course Arm III Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease receive an additional complete course of therapy
PROJECTED ACCRUAL A total of 400 patients will be accrued for 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-T91-0053N | None | None | None |
| NCI-91-C-0094 | None | None | None |