Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney

This study has been completed.
Information provided by (Responsible Party):
Case Comprehensive Cancer Center Identifier:
First received: February 26, 2009
Last updated: May 2, 2012
Last verified: May 2012

February 26, 2009
May 2, 2012
December 2005
October 2009   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: evaluated q 3 months to progression for 1 year ] [ Designated as safety issue: No ]
Follow-up scans will be done at the completion of each 8 week cycle of therapy.
Progression-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00853021 on Archive Site
  • Objective response rate (complete and partial response) [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
    To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
  • Number of patients adverse events/toxicity [ Time Frame: from start of treatment to 30 days after treatment ] [ Designated as safety issue: Yes ]
    Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 3.0) will be employed to grade observed toxicity.
  • Objective response rate (complete and partial response) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney
Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma

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.



  • To evaluate the effect of the combination of bevacizumab and aldesleukin on progression-free survival of patients with good- or intermediate-risk metastatic clear cell renal cell carcinoma.


  • To determine the objective response rate in patients receiving this regimen.
  • To determine the time to progression in patients receiving this regimen.
  • To evaluate the toxicity of this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days -14, 1, 15, 29, and 42 and aldesleukin subcutaneously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving complete response after completion of study therapy may receive 1 additional course of therapy.

After completion of study therapy, patients are followed periodically.

Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
  • Biological: aldesleukin
    SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
    Other Names:
    • rIL-2 (NSC3773364)
    • Proleukin®
    • Chiron
  • Biological: bevacizumab
    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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2009
October 2009   (final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CASE8804, P30CA043703, CASE8804, 7493
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jorge A. Garcia, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP