Bevacizumab in Treating Patients With Myelodysplastic Syndrome

May 14, 2013 updated by: Stanford University

Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • California
      • Stanford, California, United States, 94305-5750
        • Stanford Cancer Center at Stanford University Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2
  • Karnofsky 60-100%

Life expectancy:

  • More than 4 months

Hematopoietic:

  • 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

Hepatic:

  • 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

Renal:

  • 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

Cardiovascular:

  • 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

Pulmonary:

  • No pulmonary embolism

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Other:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Peter L. Greenberg, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUMC-MDA-ID-01152
  • CDR0000068778 (Registry Identifier: PDQ (Physician Data Query))
  • MDA-ID-01152
  • NCI-2771

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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