Recruiting
Phase 2

Bevacizumab & Interleukin-2

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT00301990

Conditions

Kidney Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

aldesleukin

bevacizumab

Study Details

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.

Conditions

Kidney Cancer

Study ID

NCT00301990

Start date

Sep, 2005

Status verified date

Apr, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

65 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

aldesleukin

bevacizumab

Primary outcome measure

  • Response [ Time Frame: undefined ]
  • Progression-free and overall survival [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Jonsson Comprehensive Cancer Center at UCLA

Recruiting

Los Angeles, California, United States, 90095-1781

Contacts

Clinical Trials Office - Jonsson Comprehensive Cancer Center a

888-798-0719

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Clinical Trials Office - Cardinal Bernardin Cancer Center

708-226-4357

Indiana University Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202-5289

Contacts

Clinical Trials Office - Indiana University Cancer Center

317-274-2552

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Clinical Trials Office - Beth Israel Deaconess Medical Center

617-667-9925

Barbara Ann Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201-1379

Contacts

Clinical Trials Office - Barbara Ann Karmanos Cancer Institute

313-576-9363

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756-0002

Contacts

Clinical Trials Office - Norris Cotton Cancer Center

603-650-7609cancerhelp@dartmouth.edu

Our Lady of Mercy Medical Center Comprehensive Cancer Center

Recruiting

Bronx, New York, United States, 10466

Contacts

Janice P. Dutcher, MD

718-304-7200

Providence Cancer Center at Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213-2967

Contacts

Clinical Trials Office - Providence Cancer Center at Providenc

503-215-6412

UPMC Cancer Centers

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Clinical Trials Office - UPMC Cancer Centers

412-647-8073

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232-6838

Contacts

Clinical Trials Office - Vanderbilt-Ingram Cancer Center

800-811-8480

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Geoffrey R. Weiss, MD

434-243-0066grw3k@virginia.edu

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jan 10, 2014

Last verified

Apr, 2007

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2014-01-10.