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

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
bevacizumab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLARecruiting
  • Cardinal Bernardin Cancer Center at Loyola University Medical CenterRecruiting
  • Indiana University Melvin and Bren Simon Cancer CenterRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterRecruiting
  • Our Lady of Mercy Medical Center Comprehensive Cancer CenterRecruiting
  • Providence Cancer Center at Providence Portland Medical CenterRecruiting
  • UPMC Cancer CentersRecruiting
  • Vanderbilt-Ingram Cancer CenterRecruiting
  • University of Virginia Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

Response
Progression-free and overall survival

Secondary Outcome Measures

Comparison of response and survival with historical data
Toxicity
Time to disease progression
Pharmacokinetics and pharmacodynamics
Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival
Utility of known prognostic criteria

Full Information

First Posted
March 10, 2006
Last Updated
January 9, 2014
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00301990
Brief Title
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Official Title
A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Primary Outcome Measure Information:
Title
Response
Title
Progression-free and overall survival
Secondary Outcome Measure Information:
Title
Comparison of response and survival with historical data
Title
Toxicity
Title
Time to disease progression
Title
Pharmacokinetics and pharmacodynamics
Title
Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival
Title
Utility of known prognostic criteria

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fairooz F. Kabbinavar, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Jonsson Comprehensive Cancer Center a
Phone
888-798-0719
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Cardinal Bernardin Cancer Center
Phone
708-226-4357
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Indiana University Cancer Center
Phone
317-274-2552
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Beth Israel Deaconess Medical Center
Phone
617-667-9925
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Phone
313-576-9363
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Norris Cotton Cancer Center
Phone
603-650-7609
Email
cancerhelp@dartmouth.edu
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice P. Dutcher, MD
Phone
718-304-7200
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Providence Cancer Center at Providenc
Phone
503-215-6412
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - UPMC Cancer Centers
Phone
412-647-8073
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Phone
800-811-8480
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey R. Weiss, MD
Phone
434-243-0066
Email
grw3k@virginia.edu

12. IPD Sharing Statement

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

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