CClinicalTrials.gg
Status unknownNCT00301990Updated Jan 10, 2014

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

A Phase 2 interventional study of aldesleukin and bevacizumab in Kidney Cancer, sponsored by Jonsson Comprehensive Cancer Center. Status unknown at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by Jonsson Comprehensive Cancer Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kidney Cancer

Keywords

  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 65 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
65 participants (estimated)

Interventions

  • Biologicalaldesleukin
  • Biologicalbevacizumab
06

What researchers measure

Primary outcomes

  1. Response

  2. Progression-free and overall survival

Secondary outcomes

  1. Comparison of response and survival with historical data

  2. Toxicity

  3. Time to disease progression

  4. Pharmacokinetics and pharmacodynamics

  5. Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival

  6. Utility of known prognostic criteria

07

Study locations

11 of 11 sites recruiting
  • Jonsson Comprehensive Cancer Center at UCLA
    Los Angeles, California 90095-1781, United States
    • Clinical Trials Office - Jonsson Comprehensive Cancer Center a · Contact · 888-798-0719
    Recruiting
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    Maywood, Illinois 60153, United States
    • Clinical Trials Office - Cardinal Bernardin Cancer Center · Contact · 708-226-4357
    Recruiting
  • Indiana University Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202-5289, United States
    • Clinical Trials Office - Indiana University Cancer Center · Contact · 317-274-2552
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    • Clinical Trials Office - Beth Israel Deaconess Medical Center · Contact · 617-667-9925
    Recruiting
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
    • Clinical Trials Office - Barbara Ann Karmanos Cancer Institute · Contact · 313-576-9363
    Recruiting
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756-0002, United States
    Recruiting
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
    Bronx, New York 10466, United States
    • Janice P. Dutcher, MD · Contact · 718-304-7200
    Recruiting
  • Providence Cancer Center at Providence Portland Medical Center
    Portland, Oregon 97213-2967, United States
    • Clinical Trials Office - Providence Cancer Center at Providenc · Contact · 503-215-6412
    Recruiting
  • UPMC Cancer Centers
    Pittsburgh, Pennsylvania 15232, United States
    • Clinical Trials Office - UPMC Cancer Centers · Contact · 412-647-8073
    Recruiting
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
    • Clinical Trials Office - Vanderbilt-Ingram Cancer Center · Contact · 800-811-8480
    Recruiting
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00301990
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Mar 13, 2006
Start date
Sep 2005
Last update
Jan 10, 2014

Study contacts

Fairooz F. Kabbinavar, MD
study chair · Jonsson Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

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