Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
OBJECTIVES:
Primary
- To evaluate the effect of the combination of bevacizumab and aldesleukin on
progression-free survival of patients with good- or intermediate-risk metastatic clear
cell renal cell carcinoma.
Secondary
- To determine the objective response rate in patients receiving this regimen.
- To determine the time to progression in patients receiving this regimen.
- To evaluate the toxicity of this regimen in these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days -14, 1, 15, 29, and 42
and aldesleukin subcutaneously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Courses
repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Patients achieving complete response after completion of study therapy may receive
1 additional course of therapy.
After completion of study therapy, patients are followed periodically.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Follow-up scans will be done at the completion of each 8 week cycle of therapy.
evaluated q 3 months to progression for 1 year
No
Jorge A. Garcia, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE8804
NCT00853021
December 2005
October 2009
Name | Location |
---|---|
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |