Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma (RCC) with predominantly clear cell histology Measurable disease No history of tumor-related hemorrhage No history of CNS or brain metastases PATIENT CHARACTERISTICS: Karnofsky performance status ≥ 80% Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusion or recombinant erythropoietin growth factors allowed) AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if due to liver metastases) Serum total bilirubin ≤ 2 times ULN (except for patients with Gilbert's disease) Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min FEV_1 ≥ 2.0 L or ≥ 75% of predicted Pulmonary function testing required for patients over age 50 or with significant pulmonary or smoking history No history of cerebrovascular accident or transient ischemic attacks No evidence of any of the following cardiac conditions*: Congestive heart failure Symptoms of coronary artery disease Myocardial infarction < 6 months prior to study entry Serious cardiac arrhythmias Unstable angina NOTE: *Patients > 40 years old or who have had a previous myocardial infarction > 6 months prior to study entry are required to have a negative or low probability cardiac stress test for cardiac ischemia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cancer, such as cervical carcinoma in situ, superficial bladder cancer without local recurrence, or breast cancer in situ Patients with a history of another invasive malignancy must be in complete remission for ≥ 5 years No positive serology for HIV, hepatitis B, or hepatitis C No significant co-morbid illness, such as uncontrolled diabetes or active infection, that would preclude study treatment No history of inflammatory bowel disease or other serious autoimmune disease Thyroiditis or rheumatoid arthritis allowed No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg) Proteinuria ≤ 3+ by dipstick OR proteinuria < 2 gm by 24-hour urine collection Urine protein:creatinine ration < 1.0 No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry No significant traumatic injury within the past 28 days No serious, nonhealing wound, ulcer, or bone fracture No active bleeding No history of other serious hemorrhage, bleeding diathesis, or underlying coagulopathy No history of deep venous thrombosis, clinically significant peripheral vascular disease, or other thrombotic event PRIOR CONCURRENT THERAPY: No organ allografts At least 4 weeks since prior radiotherapy or surgery and recovered No prior systemic therapy for metastatic RCC No prior bevacizumab or interleukin-2 At least 2 weeks since prior steroids No major surgery or open biopsy within the past 28 days No minor surgical procedures, fine needle aspirations, or core biopsies within the past 7 days, except central venous catheter placement No concurrent major surgery No concurrent corticosteroids or other immunosuppressants
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLARecruiting
- Cardinal Bernardin Cancer Center at Loyola University Medical CenterRecruiting
- Indiana University Melvin and Bren Simon Cancer CenterRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Barbara Ann Karmanos Cancer InstituteRecruiting
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterRecruiting
- Our Lady of Mercy Medical Center Comprehensive Cancer CenterRecruiting
- Providence Cancer Center at Providence Portland Medical CenterRecruiting
- UPMC Cancer CentersRecruiting
- Vanderbilt-Ingram Cancer CenterRecruiting
- University of Virginia Cancer CenterRecruiting