NCT00126490

Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. 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. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Determine the frequency of major response in patients with metastatic renal cell cancer treated with bevacizumab and interleukin-2. SECONDARY OBJECTIVES I. Compare the median progression-free survival and median overall survival of patients treated with this regimen with risk-stratified historical controls from published risk models. OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days and then every 3 months for at least 2 years. PROJECTED ACCRUAL: Approximately 10-38 patients will be accrued for this study within 21 months.

Conditions

• Recurrent Renal Cell Carcinoma
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given subcutaneously
BIOLOGICAL	Bevacizumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2005-03-01
• Primary completion: 2012-06-01
• Completion: 2013-08-01
• First posted: 2005-08-04
• Last updated: 2015-06-30
• Results posted: 2013-07-30

Locations

1 site across 1 country: United States