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Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma



- 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.

Inclusion Criteria


- 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

- 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

- 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

- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Follow-up scans will be done at the completion of each 8 week cycle of therapy.

Outcome Time Frame:

evaluated q 3 months to progression for 1 year

Safety Issue:


Principal Investigator

Jorge A. Garcia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

October 2009

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195