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

NCT00301990 | Unknown Phase 2

• 3 other identifiers: CDR0000460074UCLA-050658-01DMS-W0454
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Response

• Progression-free and overall survival

Secondary Outcomes (6)

• 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

Interventions

aldesleukin BIOLOGICAL

bevacizumab BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

RECRUITING

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

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

The Bronx, New York, 10466, United States

RECRUITING

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

RECRUITING

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin; Bevacizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Fairooz F. Kabbinavar, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 13, 2006
• Study Start: September 1, 2005
• Last Updated: January 10, 2014

Record last verified: 2007-04

Locations

US (11)