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Bevacizumab in Treating Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022048
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 deliver cancer-killing substances to them.

PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Biological: bevacizumab Phase 1 Phase 2

Detailed Description:


  • Determine the hematologic responses, including changes in hemoglobin levels, neutrophil counts, platelet counts, and percentage of bone marrow blasts, in patients with myelodysplastic syndrome treated with bevacizumab.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the tolerance in patients treated with this regimen.
  • Determine bone marrow cytogenetic responses in patients treated with this regimen.
  • Determine bone marrow microvessel density in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to International Prognostic Scoring System risk status (low (low or intermediate-1) vs high (intermediate-2 or high)).

Patients receive bevacizumab IV over 30-90 minutes. Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 1, 3, 5, 7, and 9.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)
Study Start Date : August 2001
Study Completion Date : November 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed myelodysplastic syndrome (MDS)

    • Refractory anemia (RA)
    • RA with excess blasts (RAEB)
    • RAEB in transformation
    • RA with ringed sideroblasts
    • Non-proliferative chronic myelomonocytic leukemia (WBC less than 12,000/mm^3)
  • At least 1 of the following cytopenias:

    • Untransfused hemoglobin no greater than 10.0 g/dL and/or red cell transfusion dependent
    • Absolute neutrophil count no greater than 1,800/mm^3 (neutropenia)
    • Platelet count no greater than 100,000/mm^3 (thrombocytopenia)
  • No secondary MDS
  • No known brain metastases



  • 18 and over

Performance status:

  • ECOG 0-2
  • Karnofsky 60-100%

Life expectancy:

  • More than 4 months


  • See Disease Characteristics
  • Platelet count at least 20,000/mm^3
  • No hemorrhagic illness within the past 3 weeks
  • No hemolysis
  • No iron deficiency
  • No active blood loss


  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 2.0 mg/dL
  • INR less than 2.0
  • PTT less than 1.5 times ULN


  • Creatinine no greater than 2.0 mg/dL
  • No renal dysfunction requiring dialysis within the past 6 months
  • No nephrotic syndrome within the past 6 months


  • No myocardial infraction within the past 6 months
  • No severe or unstable angina within the past 6 months
  • No severe peripheral vascular disease (ischemic rest pain, non-healing wound or ulcer, or tissue loss) within the past 6 months
  • No uncontrolled hypertension within the past 6 months
  • No transient ischemic attack within the past 6 months
  • No cerebrovascular accident within the past 6 months
  • No deep venous or arterial thrombosis
  • No coronary artery disease
  • No symptomatic congestive heart failure (New York Heart Association class II-IV heart disease)
  • No cardiac arrhythmia
  • No vascular illness within the past 3 weeks


  • No pulmonary embolism


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy except localized squamous cell or basal cell skin cancer

    • Prior cured malignancy allowed
  • No trauma within the past 3 weeks
  • No significant inflammatory disease within the past 3 weeks
  • No serious non-healing wound, ulcer, or bone fracture
  • No hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No other active severe disease
  • No infection
  • No psychiatric illness or social situation that would preclude study compliance
  • HIV negative


Biologic therapy:

  • No prior allogeneic bone marrow transplantation
  • At least 30 days since prior biologic response modifiers
  • At least 30 days since prior hematopoietic growth factors
  • At least 30 days since prior thalidomide
  • No concurrent thalidomide
  • No other concurrent biologic response modifiers
  • No concurrent hematopoietic growth factors (including epoetin alfa)
  • Concurrent filgrastim (G-CSF) for febrile neutropenia allowed
  • Concurrent transfusions allowed


  • At least 30 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroid therapy (more than 10 mg/day of prednisone or equivalent steroid dose) except for pre-medication for transfusions


  • At least 30 days since prior radiotherapy
  • No concurrent radiotherapy


  • At least 3 weeks since prior surgery (including biopsy of visceral organ)


  • At least 10 days since prior anticoagulants
  • No concurrent cytotoxic agents
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022048

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5750
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Study Chair: Peter L. Greenberg, MD Stanford University Identifier: NCT00022048     History of Changes
Other Study ID Numbers: SUMC-MDA-ID-01152
CDR0000068778 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: October 2004

Keywords provided by National Cancer Institute (NCI):
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
atypical chronic myeloid leukemia, BCR-ABL1 negative

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents