Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Condition: Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Aldesleukin; Bevacizumab; Laboratory Biomarker Analysis
Intervention description: Given subcutaneously; Given IV; Correlative studies
Intervention MeSH terms: Aldesleukin; Bevacizumab; Antineoplastic Agents, Immunological; Interleukin-2; Endothelial Growth Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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