Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney
Condition: Kidney Cancer
MeSH terms: Carcinoma; Kidney Neoplasms
Intervention: aldesleukin; bevacizumab
Intervention description: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.; Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
Intervention MeSH terms: Aldesleukin; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: clear cell renal cell carcinoma; recurrent renal cell cancer; stage IV renal cell cancer

Summary:

      RATIONALE: 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. Biological therapies, such as
      aldesleukin, may stimulate the immune system in different ways and stop tumor cells from
      growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with
      aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed renal cell carcinoma (RCC) of clear cell
             histology with or without sarcomatoid features

               -  Metastatic disease

               -  No non-clear cell RCC (i.e., papillary, collecting-duct, or chromophobe)

          -  Good- or intermediate-risk category as defined by having ≤ 2 of the following factors:

               -  No prior nephrectomy

               -  Karnofsky performance status < 80%

               -  Hemoglobin < 12 g/dL

               -  Corrected calcium > 10.0 mg/dL

               -  LDH > 1.5 times upper limit of normal (ULN)

          -  Must have undergone a nephrectomy at least 28 days ago

          -  Measurable or evaluable disease by RECIST

          -  No significant effusions and/or ascites

          -  No prior or concurrent brain or CNS metastasis

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy of ≥ 3 months

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.5 g/dL

          -  Creatinine ≤ 2.0 mg/dL

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST ≤ 5.0 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN (≤ 10 times ULN with bone metastasis)

          -  Calcium ≤ 12 mg/dL

          -  Urine protein:creatinine ratio ≤ 1.0

          -  INR ≤ 1.5 (unless receiving warfarin therapy)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No uncontrolled seizure disorder

          -  No known HIV positivity

          -  No local or systemic infections requiring IV antibiotics within the past 28 days

          -  No significant traumatic injury in the past 28 days

          -  No serious non-healing wound, ulcer, or acute bone fracture

          -  No evidence of bleeding diathesis or coagulopathy

          -  No other malignancy except basal cell or squamous cell carcinoma of the skin,
             carcinoma in-situ of the uterine cervix, or any malignancy treated with curative
             intent and in complete remission for > 3 years

          -  No history of serious systemic or severe cardiovascular disease, including any of the
             following:

               -  Arterial thromboembolic event (including transient ischemic attack)

               -  Cerebrovascular accident

               -  Unstable angina

               -  Myocardial infarction within the past 6 months

               -  Uncontrolled hypertension (BP > 160/110 mm Hg on medication)

               -  Uncontrolled cardiac arrhythmia

               -  Congestive heart failure

               -  Angina pectoris

               -  NYHA class III-IV cardiovascular disease

               -  Peripheral vascular disease ≥ grade II

          -  No history of abdominal fistula and/or bowel or gastric perforation within the past 6
             months

          -  No history of other diseases, metabolic dysfunction, or physical or laboratory
             examination findings giving reasonable suspicion of a disease or condition that
             contraindicate the use of investigational drugs, or that might affect the
             interpretation of study results, or that render patient at high-risk for treatment
             complications

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior organ allografts

          -  No prior systemic therapy for metastatic clear cell renal cell carcinoma

          -  At least 4 weeks since prior radiotherapy and recovered

               -  Radiotherapy for control of pain from skeletal lesions allowed within the past 28
                  days

          -  More than 12 months since prior adjuvant therapy

          -  More than 7 days since prior fine-needle aspirations or core biopsies

          -  More than 28 days since prior and no concurrent major surgery requiring general
             anesthesia or open biopsy

          -  No concurrent aspirin, corticosteroids (except at replacement doses), barbiturates, or
             other investigational agents