NCT00853021

Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney

Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Jorge A. Garcia, MD · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin	SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
BIOLOGICAL	bevacizumab	Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-02-27
• Last updated: 2019-06-05
• Results posted: 2015-08-24

Locations

1 site across 1 country: United States