Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
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
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer|
- Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Number of Evaluable Participants With Overall Survival (OS) at 2 Years [ Time Frame: 2 years from start of treatment ] [ Designated as safety issue: No ]Overall Survival tabulation at 2 years from start of treatment.
- Number of Evaluable Participants With Progression Free Survival (PFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function [ Time Frame: At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment ] [ Designated as safety issue: No ]Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.
- Number of Participants With Possibly Related Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after completion of treatment ] [ Designated as safety issue: Yes ]Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
|Study Start Date:||March 2005|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bevacizumab, aldesleukin)
Patients received 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 repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
Other Names:Biological: aldesleukin
Other Names:Other: laboratory biomarker analysis
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.
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.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Mayer Fishman||H. Lee Moffitt Cancer Center and Research Institute|