Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080977
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2004-04-07
Brief Title:
High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma Kidney Cancer That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
Sponsor:
Blumenthal Cancer Center at Carolinas Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
Status:
UNKNOWN
Status Verified Date:
2005-06
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 Interleukin-2 may stimulate a persons white blood cells to kill renal cell carcinoma kidney cancer cells
PURPOSE This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2
PURPOSE This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2
Detailed Description:
OBJECTIVES
Determine the response rate complete partial and minor in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 IL-2 when treated with high-dose intravenous IL-2
Determine the overall survival disease-free survival and time to progression in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a pilot study
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses course 1
Patients are assesed for response 2 months after initiation of treatment Patients with responding or stable disease receive a second course of therapy Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity
Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the response rate complete partial and minor in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 IL-2 when treated with high-dose intravenous IL-2
Determine the overall survival disease-free survival and time to progression in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a pilot study
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses course 1
Patients are assesed for response 2 months after initiation of treatment Patients with responding or stable disease receive a second course of therapy Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity
Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CMC-10-01-01AH | None | None | None |