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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301990
First received: March 10, 2006
Last updated: January 9, 2014
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Biological: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of response and survival with historical data [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Pharmacokinetics and pharmacodynamics [ Designated as safety issue: No ]
  • Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival [ Designated as safety issue: Yes ]
  • Utility of known prognostic criteria [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: September 2005
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-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301990

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a    888-798-0719      
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center    317-274-2552      
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center    617-667-9925      
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    313-576-9363      
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center    603-650-7609    cancerhelp@dartmouth.edu   
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center Recruiting
Bronx, New York, United States, 10466
Contact: Janice P. Dutcher, MD    718-304-7200      
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc    503-215-6412      
United States, Pennsylvania
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers    412-647-8073      
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Geoffrey R. Weiss, MD    434-243-0066    grw3k@virginia.edu   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Fairooz F. Kabbinavar, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00301990     History of Changes
Obsolete Identifiers: NCT00142142
Other Study ID Numbers: CDR0000460074, UCLA-050658-01, DMS-W0454
Study First Received: March 10, 2006
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Aldesleukin
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014