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Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290810
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Drug: bevacizumab
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Bevacizumab to Prevent or Delay Disease Progression in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed treatment success [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Correlation of VEGF receptor-2 and phosphorylation levels with response and toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: December 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess the treatment success rate of bevacizumab in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).
  • Assess the toxicity associated with this drug in patients with relapsed or refractory CLL.

Secondary

  • Assess whether treatment with bevacizumab is selecting out a resident clone.
  • Determine whether bevacizumab can be synergistic with other chemotherapeutic drugs, such as chlorambucil or fludarabine.
  • Assess whether marrow vascularity is increased at study entry and if it is modulated following therapy with bevacizumab.
  • Examine the association between vascular endothelial growth factor (VEGF) plasma levels at baseline and clinical responses to bevacizumab.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following phenotypic characteristics:

    • Predominant population of cells share both B-cell antigens (CD19, CD20, or CD23) as well as the T-cell antigen (CD-5), in the absence of other pan-T-cell markers (CD-3, CD-2, etc.)

      • Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11;14) by fluorescent in situ hybridization (FISH)
    • Dim surface immunoglobulin expression
    • Exclusively kappa and lambda light chains NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
  • Peripheral blood absolute lymphocyte count > 5,000/mm^3

    • Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
  • Requires chemotherapy, as indicated by any of the following:

    • Disease related symptoms, including the following:

      • Weight loss ≥ 10% within the previous 6 months
      • Extreme fatigue
      • Fevers > 100.5°F for 2 weeks without evidence of infection
      • Night sweats without evidence of infection
    • Evidence of progressive marrow failure, as manifested by the development of or worsening anemia (hemoglobin ≤ 10 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm^3)
    • Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly
    • Measurable and progressive lymphadenopathy
    • Measurable (i.e., > 5,000/mm^3) and progressive lymphocytosis
  • Progressive disease or relapsed after or refractory to 1 course of an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen
  • No marrow function attributable to dysplasia related to prior therapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0, 1, or 2
  • Serum creatinine < 2 mg/dL

    • If serum creatinine > 1.5 mg/dL but < 2 mg/dL, creatinine clearance must be ≥ 30 mL/min
  • Platelet count > 30,000/mm^3
  • Direct bilirubin ≤ 2 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other second malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No New York Heart Association class III or IV heart failure
  • No blood pressure > 150/90 mm Hg
  • No unstable angina
  • No myocardial infarction or stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • Urine protein:creatinine (UPC) ratio ≤ 1.0

    • Patients with a UPC ratio > 1.0 must undergo a 23-hour urine collection and must demonstrate < 1 gram of protein per day
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, non-healing wound, ulcer, or bone fracture
  • No active infections requiring oral or intravenous antibiotics
  • No active bleeding or pathological conditions that carry a high risk of bleeding (e.g., known varices)
  • No thrombocytopenia requiring transfusion

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior participation in an experimental drug study
  • At least 8 weeks since prior rituximab
  • At least 6 weeks since prior chemotherapy
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior minor surgery, fine needle aspirations, or core biopsies
  • No concurrent major surgery
  • No concurrent participation in another experimental drug study
  • Concurrent full-dose warfarin or low molecular weight heparin allowed provided patient is on a stable dose AND INR is in range
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290810

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, District of Columbia
Howard University Cancer Center Recruiting
Washington, District of Columbia, United States, 20060
Contact: Clinical Trials Office - Howard University Cancer Center     202-806-9122        
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Patricia M. LoRusso, DO     313-745-1238        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Paula M. Fracasso, MD, PhD     314-454-8817        
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Tait D. Shanafelt, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000459933, MAYO-MC048C, NCI-7211
Study First Received: February 9, 2006
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00290810  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Disease Progression
Bevacizumab
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009