Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney
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. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma|
- Progression-free survival [ Time Frame: evaluated q 3 months to progression for 1 year ] [ Designated as safety issue: No ]Follow-up scans will be done at the completion of each 8 week cycle of therapy.
- Objective response rate (complete and partial response) [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
- Number of patients adverse events/toxicity [ Time Frame: from start of treatment to 30 days after treatment ] [ Designated as safety issue: Yes ]Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 3.0) will be employed to grade observed toxicity.
|Study Start Date:||December 2005|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- rIL-2 (NSC3773364)
- 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.
- 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.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jorge A. Garcia, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|