Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301990
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2006-03-10
Brief Title:
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma RCC A Cytokine Working Group CWG Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Interleukin-2 may stimulate the white blood cells to kill tumor cells Giving bevacizumab together with interleukin-2 may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Estimate the response progression-free survival and overall survival of patients with metastatic renal cell carcinoma RCC treated with bevacizumab and high-dose interleukin-2 IL-2
Secondary
Compare the response and survival of patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone
Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC with the historical data of patients treated with high-dose IL-2 alone in terms of number of doses of IL-2 administered during the first course of therapy toxicity after the scheduled ninth dose of IL-2 and frequency of grade III and IV or unexpected or rare toxicities
Compare the time to disease progression in patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone
Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2 during course 1
Correlate serum vascular endothelial growth factor VEGF levels DC function TCR zeta chain expression and arginase or arginine levels with toxicity response and survival of patients treated with this regimen
Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome
OUTLINE This is a multicenter study Patients are stratified according to prognosis good vs intermediate vs poor
Patients receive bevacizumab IV over 30-90 minutes on days -13 1 15 29 43 57 and 71 during course 1 and on days 1 15 29 43 57 and 71 during courses 2 and 3 Patients also receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19 Treatment repeats every 84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study
Primary
Estimate the response progression-free survival and overall survival of patients with metastatic renal cell carcinoma RCC treated with bevacizumab and high-dose interleukin-2 IL-2
Secondary
Compare the response and survival of patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone
Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC with the historical data of patients treated with high-dose IL-2 alone in terms of number of doses of IL-2 administered during the first course of therapy toxicity after the scheduled ninth dose of IL-2 and frequency of grade III and IV or unexpected or rare toxicities
Compare the time to disease progression in patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone
Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2 during course 1
Correlate serum vascular endothelial growth factor VEGF levels DC function TCR zeta chain expression and arginase or arginine levels with toxicity response and survival of patients treated with this regimen
Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome
OUTLINE This is a multicenter study Patients are stratified according to prognosis good vs intermediate vs poor
Patients receive bevacizumab IV over 30-90 minutes on days -13 1 15 29 43 57 and 71 during course 1 and on days 1 15 29 43 57 and 71 during courses 2 and 3 Patients also receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19 Treatment repeats every 84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 65 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 |
|---|---|---|---|
| DMS-W0454 | None | None | None |
| UCLA-050658-01 | None | None | None |