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Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers

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.
ClinicalTrials.gov Identifier: NCT00015951
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2009
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland

Brief Summary:

RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer.

PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.


Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Biological: bevacizumab Drug: cytarabine Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the clinical effectiveness of bevacizumab, cytarabine, and mitoxantrone in patients with poor-risk hematologic malignancies.
  • Determine the toxic effects of this regimen in these patients.
  • Determine whether this regimen can induce cell apoptosis in these patients.
  • Determine the effects of bevacizumab on coagulation profiles in these patients.

OUTLINE: This is a multicenter study.

Patients receive cytarabine IV continuously over 72 hours on days 1-3, mitoxantrone IV over 30-60 minutes on day 4, and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 12-45 patients will be accrued for this study within 1-3 years.


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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Recombinant Human Monoclonal Anti-Vascular Endothelial Growth Factor Antibody (rhuMAB VEGF) Bevacizumab (NSC #704865, IND # 7,921) Administered in Times Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs)
Study Start Date : April 2001
Actual Primary Completion Date : April 2003
Actual Study Completion Date : March 2004






Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed poor-risk hematologic malignancy

    • Relapsed or refractory acute myelogenous leukemia (AML)

      • Primary induction failure
      • Myelodysplasia(MDS)-related AML
      • Secondary AML
    • Relapsed or refractory MDS

      • Primary induction failure
      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia
    • Chronic myelogenous leukemia in blast crisis
  • Failure of prior primary induction therapy or relapse after achieving complete remission allowed only if no more than 3 courses of prior induction/reinduction therapy were received
  • No hyperleukocytosis (50,000 or more leukemic blasts/mm3)
  • No active CNS leukemia

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • No disseminated intravascular coagulation

Hepatic:

  • AST/ALT no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal
  • Bilirubin no greater than 1.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Cardiovascular:

  • LVEF at least 45% by MUGA or echocardiogram
  • No myocardial infarction within the past 3 months
  • No history of severe coronary artery disease
  • No cardiomyopathy
  • No New York Heart Association class III or IV heart disease (congestive heart failure)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active uncontrolled infection
  • No history of cytarabine-related neurotoxicity
  • No evidence of graft-versus-host disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 week since prior hematopoietic growth factors including epoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF)
  • At least 1 week since prior interleukin-3 or interleukin-11
  • At least 4 weeks since prior autologous stem cell transplantation
  • At least 90 days since prior allogeneic stem cell transplantation
  • No other concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No prior cytarabine administered as a 72-hour continuous infusion followed by mitoxantrone IV over 30 minutes
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 2 weeks since prior immunosuppressive therapy
  • No other concurrent investigational or commercially available antitumor therapy

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 ClinicalTrials.gov identifier (NCT number): NCT00015951


Locations
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United States, Georgia
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342-1601
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
University of Maryland
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
Investigators
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Study Chair: Judith E. Karp, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: UM Greenebaum Cancer Center
ClinicalTrials.gov Identifier: NCT00015951     History of Changes
Other Study ID Numbers: CDR0000068576
MSGCC-0076
NCI-2490
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by University of Maryland:
recurrent adult acute myeloid leukemia
relapsing chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
secondary acute myeloid leukemia
previously treated myelodysplastic syndromes
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
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Mitoxantrone
Syndrome
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Bevacizumab
Cytarabine
Endothelial Growth Factors
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors