Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006864
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2000-12-06
Brief Title:
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Interleukin-2 In An Alternative Dose The Iliad Trial Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
Status:
COMPLETED
Status Verified Date:
2014-01
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 kidney cancer cells
PURPOSE Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer
PURPOSE Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the overall response rate complete and partial response rates and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2
Determine the overall survival one-year progression-free survival and two-year progression-free survival in patients treated with this regimen
Determine the incidence of adverse events in these patients
OUTLINE This is a multicenter study
Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 464 patients will be accrued for this study
Determine the overall response rate complete and partial response rates and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2
Determine the overall survival one-year progression-free survival and two-year progression-free survival in patients treated with this regimen
Determine the incidence of adverse events in these patients
OUTLINE This is a multicenter study
Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 464 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-G00-1875 | None | None | None |
| CWRU-CHIR-1899 | None | None | None |
| CHIR-MA-99-01 | None | None | None |
| CWRU-010002 | None | None | None |