Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126490
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2005-08-02
Brief Title:
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer 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
Detailed Description:
PRIMARY OBJECTIVES
I Determine the frequency of major response in patients with metastatic renal cell cancer treated with bevacizumab and interleukin-2
SECONDARY OBJECTIVES I Compare the median progression-free survival and median overall survival of patients treated with this regimen with risk-stratified historical controls from published risk models
OUTLINE
Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1 3 5 7 9 and 11 Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10 Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease then receive bevacizumab alone in weeks 1 3 5 7 9 and 11 Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 30 days and then every 3 months for at least 2 years
PROJECTED ACCRUAL Approximately 10-38 patients will be accrued for this study within 21 months
I Determine the frequency of major response in patients with metastatic renal cell cancer treated with bevacizumab and interleukin-2
SECONDARY OBJECTIVES I Compare the median progression-free survival and median overall survival of patients treated with this regimen with risk-stratified historical controls from published risk models
OUTLINE
Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1 3 5 7 9 and 11 Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10 Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease then receive bevacizumab alone in weeks 1 3 5 7 9 and 11 Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 30 days and then every 3 months for at least 2 years
PROJECTED ACCRUAL Approximately 10-38 patients will be accrued for this study within 21 months
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 |
|---|---|---|---|
| P30CA076292 | NIH | CTEP | httpsreporternihgovquickSearchP30CA076292 |
| NCI-2012-02663 | REGISTRY | None | None |
| CDR0000434852 | None | None | None |
| NCI-6438 | None | None | None |
| MCC-IRB-102782 | None | None | None |
| MCC 13921 | OTHER | None | None |
| 6438 | OTHER | None | None |