Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019539
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2009-01-09
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Study of Monoclonal Antibody VEGF in Patients With Unresectable Advanced Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them
PURPOSE Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed
PURPOSE Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the effect of monoclonal antibody VEGF on time to progression angiogenesis and overall survival in patients with unresectable advanced renal cell cancer
II Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen
III Evaluate the toxicity of this regimen in these patients
PROTOCOL OUTLINE This is a randomized study Patients are stratified by prior interleukin-2 therapy yes vs no
Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF Following an initial loading dose patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression Patients who are given placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications
PROJECTED ACCRUAL
A total of 150 patients will be accrued for this study over 2 years
II Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen
III Evaluate the toxicity of this regimen in these patients
PROTOCOL OUTLINE This is a randomized study Patients are stratified by prior interleukin-2 therapy yes vs no
Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF Following an initial loading dose patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression Patients who are given placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications
PROJECTED ACCRUAL
A total of 150 patients will be accrued for this study over 2 years
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-T98-0035 | None | None | None |
| NCI-98-C-0159 | None | None | None |