Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Recurrent Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed renal cell cancer Metastatic disease More than 75% clear cell histology Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No prior refractory disease, defined as clinical or radiologic progression, during or within 3 months after completion of prior interleukin-2 (IL-2) Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the following criteria: Hemoglobin > 10 g/dL (except for patients with hereditary hemoglobinopathy) ECOG performance status 0-1 (required) Calcium normal (corrected) Patients with hypercalcemia due to malignancy allowed provided it has been controlled for > 1 month Primary tumor treated or resected by complete nephrectomy, partial nephrectomy, radiofrequency ablation, or other local ablation Lactic dehydrogenase < 1.5 times upper limit of normal (ULN) No history of or current brain or CNS metastasis by CT scan or MRI within the past 30 days Performance status - ECOG 0-1 More than 4 months Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 75,000/mm^3 No history of bleeding diathesis PTT < 1.5 times ULN INR < 1.5 Bilirubin ≤ 1.5 times ULN AST and ALT ≤ 2.5 times ULN No chronic hepatitis B or C Creatinine ≤ 2.0 mg/dL No proteinuria* by dipstick urinalysis Urine protein ≤ 1,000 mg by 24-hour urine collection No symptomatic congestive heart failure No uncontrolled hypertension, defined as systolic blood pressure (BP) > 160 mm Hg and diastolic BP > 90 mm Hg No cardiac arrhythmia No peripheral vascular disease ≥ grade 2 No clinically significant peripheral artery disease None of the following arterial thromboembolic events within the past 6 months: Transient ischemic attack Cerebrovascular accident Unstable angina pectoris Myocardial infarction Not pregnant No nursing during and for 3 months after completion of study treatment Negative pregnancy test Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment No active infection requiring parenteral antibiotics No known HIV positivity No history of allergic reaction to antibody drugs or IL-2 No psychiatric illness or social situation that would preclude study compliance No non-healing wound or fracture No insulin-dependent diabetes No other uncontrolled illness No other malignancy requiring active treatment within the past 2 years except nonmelanoma skin cancer No prior bevacizumab At least 6 months since prior immunotherapy containing IL-2 At least 2 months since prior investigational antibodies More than 4 weeks since prior conventional cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent corticosteroids except replacement corticosteroids for adrenal insufficiency OR inhaled steroids for chronic obstructive pulmonary disease, asthma, or allergic rhinitis More than 3 weeks since prior radiotherapy and recovered No prior radiotherapy to the only site of measurable disease unless there has been subsequent disease progression More than 4 weeks since prior major surgery At least 24 hours since prior minor surgical procedure, placement of vascular access device, or fine needle aspiration At least 30 days since prior and no other concurrent investigational agents More than 10 days since prior anticoagulants Low-dose anticoagulants for maintenance of vascular access device patency allowed No concurrent therapeutic warfarin, including warfarin for treatment of deep vein thrombosis or pulmonary embolism No other concurrent anticancer therapy
Sites / Locations
- Moffitt Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (bevacizumab, aldesleukin)
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.