Status:
UNKNOWN
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * Estimate the response, progression-free survival, and overall survival of patients with metastatic renal cell carcinoma (RCC) treated with bevacizumab and high-dose interleukin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma (RCC) with predominantly clear cell histology
- Measurable disease
- No history of tumor-related hemorrhage
- No history of CNS or brain metastases
- PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 80%
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (transfusion or recombinant erythropoietin growth factors allowed)
- AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
- Serum total bilirubin ≤ 2 times ULN (except for patients with Gilbert's disease)
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- FEV\_1 ≥ 2.0 L or ≥ 75% of predicted
- Pulmonary function testing required for patients over age 50 or with significant pulmonary or smoking history
- No history of cerebrovascular accident or transient ischemic attacks
- No evidence of any of the following cardiac conditions\*:
- Congestive heart failure
- Symptoms of coronary artery disease
- Myocardial infarction \< 6 months prior to study entry
- Serious cardiac arrhythmias
- Unstable angina NOTE: \*Patients \> 40 years old or who have had a previous myocardial infarction \> 6 months prior to study entry are required to have a negative or low probability cardiac stress test for cardiac ischemia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cancer, such as cervical carcinoma in situ, superficial bladder cancer without local recurrence, or breast cancer in situ
- Patients with a history of another invasive malignancy must be in complete remission for ≥ 5 years
- No positive serology for HIV, hepatitis B, or hepatitis C
- No significant co-morbid illness, such as uncontrolled diabetes or active infection, that would preclude study treatment
- No history of inflammatory bowel disease or other serious autoimmune disease
- Thyroiditis or rheumatoid arthritis allowed
- No uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg)
- Proteinuria ≤ 3+ by dipstick OR proteinuria \< 2 gm by 24-hour urine collection
- Urine protein:creatinine ration \< 1.0
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
- No significant traumatic injury within the past 28 days
- No serious, nonhealing wound, ulcer, or bone fracture
- No active bleeding
- No history of other serious hemorrhage, bleeding diathesis, or underlying coagulopathy
- No history of deep venous thrombosis, clinically significant peripheral vascular disease, or other thrombotic event
- PRIOR CONCURRENT THERAPY:
- No organ allografts
- At least 4 weeks since prior radiotherapy or surgery and recovered
- No prior systemic therapy for metastatic RCC
- No prior bevacizumab or interleukin-2
- At least 2 weeks since prior steroids
- No major surgery or open biopsy within the past 28 days
- No minor surgical procedures, fine needle aspirations, or core biopsies within the past 7 days, except central venous catheter placement
- No concurrent major surgery
- No concurrent corticosteroids or other immunosuppressants
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00301990
Start Date
September 1 2005
Last Update
January 10 2014
Active Locations (11)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
2
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215