Bevacizumab in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022048
First received: August 10, 2001
Last updated: May 14, 2013
Last verified: October 2004
  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 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 Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Biological: bevacizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:


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

Study Start Date: August 2001
Study Completion Date: November 2004
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022048

Locations
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
Investigators
Study Chair: Peter L. Greenberg, MD Stanford University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022048     History of Changes
Other Study ID Numbers: SUMC-MDA-ID-01152, CDR0000068778, MDA-ID-01152, NCI-2771
Study First Received: August 10, 2001
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

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:
Neoplasms
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Histologic Type
Disease
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014