Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:September 2005

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A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study

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. Interleukin-2 may stimulate the
white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may
kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with
interleukin-2 works in treating patients with metastatic kidney cancer.

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-2 (IL-2).

Secondary

- Compare the response and survival of patients with metastatic RCC treated with
bevacizumab and high-dose IL-2 with the historical data of patients treated with
high-dose IL-2 alone.

- Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC
with the historical data of patients treated with high-dose IL-2 alone, in terms of
number of doses of IL-2 administered during the first course of therapy, toxicity after
the scheduled ninth dose of IL-2, and frequency of grade III and IV or unexpected or
rare toxicities.

- Compare the time to disease progression in patients with metastatic RCC treated with
bevacizumab and high-dose IL-2 with the historical data of patients treated with
high-dose IL-2 alone.

- Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2
during course 1.

- Correlate serum vascular endothelial growth factor (VEGF) levels, DC function, TCR zeta
chain expression, and arginase or arginine levels with toxicity, response, and survival
of patients treated with this regimen.

- Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome.

OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (good
vs intermediate vs poor).

Patients receive bevacizumab IV over 30-90 minutes on days -13, 1, 15, 29, 43, 57, and 71
during course 1 and on days 1, 15, 29, 43, 57, and 71 during courses 2 and 3. Patients also
receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19. Treatment repeats every
84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

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
We found this trial at
11
sites
Pittsburgh, Pennsylvania 15232
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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Charlottesville, VA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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Lebanon, NH
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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Los Angeles, CA
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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Bronx, NY
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Maywood, IL
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4805 NE Glisan St
Portland, Oregon 97213
(503) 215-1111
Providence Cancer Center at Providence Portland Medical Center We strive to give those we serve...
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Portland, OR
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