Kidney Cancer Clinical Trial
Official title:
Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
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.
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 immunomodulatory effects of this regimen in patients
- 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.
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