Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney

NCT00853021 | Completed Phase 2 Results DMC

• 3 other identifiers: CASE8804P30CA0437037493
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.

Conditions

Kidney Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.

  From baseline (day -14) to disease progression (reported at 2 years)

Secondary Outcomes (3)

• Objective Response Rate (Complete and Partial Response)

  4 weeks after end of treatment

• Percentage of Patients With Constitutional Adverse Events

  From start of treatment to 30 days after treatment

• Percentage of Patients With Neutropenia

  From start of treatment to 30 days after treatment

Other Outcomes (6)

• Peripheral Blood CD1c+ Myeloid Dendritic Cells

  Baseline (day -14), Beginning and end of cycle 1 (day 1, 57)

• CD303+ Plasmacytoid Dendritic Cells

  Baseline (day -14), beginning and end of cycle 1 (day 1, 57)

• IL-8 Levels

  Baseline (day -14), beginning and end of cycle 1 (day 1, 57)

Study Arms (1)

Bevacizumab and Aldesleukin

EXPERIMENTAL

Biological: aldesleukin; Biological: bevacizumab

Interventions

aldesleukin BIOLOGICAL

SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.

Also known as: rIL-2 (NSC3773364), Proleukin®, Chiron

Bevacizumab and Aldesleukin

bevacizumab BIOLOGICAL

Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.

Bevacizumab and Aldesleukin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma (RCC) of clear cell histology with or without sarcomatoid features * Metastatic disease * No non-clear cell RCC (i.e., papillary, collecting-duct, or chromophobe) * Good- or intermediate-risk category as defined by having ≤ 2 of the following factors: * No prior nephrectomy * Karnofsky performance status \< 80% * Hemoglobin \< 12 g/dL * Corrected calcium \> 10.0 mg/dL * LDH \> 1.5 times upper limit of normal (ULN) * Must have undergone a nephrectomy at least 28 days ago * Measurable or evaluable disease by RECIST * No significant effusions and/or ascites * No prior or concurrent brain or CNS metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy of ≥ 3 months * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.5 g/dL * Creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 1.5 mg/dL * AST ≤ 5.0 times ULN * Alkaline phosphatase ≤ 2.5 times ULN (≤ 10 times ULN with bone metastasis) * Calcium ≤ 12 mg/dL * Urine protein:creatinine ratio ≤ 1.0 * INR ≤ 1.5 (unless receiving warfarin therapy) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled seizure disorder * No known HIV positivity * No local or systemic infections requiring IV antibiotics within the past 28 days * No significant traumatic injury in the past 28 days * No serious non-healing wound, ulcer, or acute bone fracture * No evidence of bleeding diathesis or coagulopathy * No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in-situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for \> 3 years * No history of serious systemic or severe cardiovascular disease, including any of the following: * Arterial thromboembolic event (including transient ischemic attack) * Cerebrovascular accident * Unstable angina * Myocardial infarction within the past 6 months * Uncontrolled hypertension (BP \> 160/110 mm Hg on medication) * Uncontrolled cardiac arrhythmia * Congestive heart failure * Angina pectoris * NYHA class III-IV cardiovascular disease * Peripheral vascular disease ≥ grade II * No history of abdominal fistula and/or bowel or gastric perforation within the past 6 months * No history of other diseases, metabolic dysfunction, or physical or laboratory examination findings giving reasonable suspicion of a disease or condition that contraindicate the use of investigational drugs, or that might affect the interpretation of study results, or that render patient at high-risk for treatment complications PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior organ allografts * No prior systemic therapy for metastatic clear cell renal cell carcinoma * At least 4 weeks since prior radiotherapy and recovered * Radiotherapy for control of pain from skeletal lesions allowed within the past 28 days * More than 12 months since prior adjuvant therapy * More than 7 days since prior fine-needle aspirations or core biopsies * More than 28 days since prior and no concurrent major surgery requiring general anesthesia or open biopsy * No concurrent aspirin, corticosteroids (except at replacement doses), barbiturates, or other investigational agents

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

Sponsors & Collaborators

• Jorge A. Garcia, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin; chiron; 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

Results Point of Contact

• Title: Dr. Jorge Garcia
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

garciaj4@ccf.org

216-444-7774

Study Officials

• Jorge A. Garcia, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: December 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 5, 2019
• Results First Posted: August 24, 2015

Record last verified: 2019-05

Locations

US (1)