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Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
This study is ongoing, but not recruiting participants.
First Received: May 6, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015951
  Purpose

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 Intervention Phase
Leukemia
Myelodysplastic Syndromes
Biological: bevacizumab
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Phase II

Study Type: Interventional
Study Design: 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 Mitoxanetrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs)

Resource links provided by NLM:


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

Study Start Date: April 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015951

Locations
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 Greenebaum Cancer Center
Investigators
Study Chair: Judith E. Karp, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068576, MSGCC-0076, NCI-2490
Study First Received: May 6, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00015951     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Blast Crisis
Chronic Myelomonocytic Leukemia
Immunologic Factors
Hematologic Neoplasms
Precancerous Conditions
Bevacizumab
Leukemia, Myeloid, Acute
Refractory Anemia
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Anemia, Refractory
Acute Myeloid Leukemia, Adult
Neoplasm Metastasis
Mitogens
Analgesics
Cytarabine
Immunoglobulins
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Anemia
Leukemia, Myeloid
Endothelial Growth Factors
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Recurrence

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Analgesics
Cytarabine
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Growth Substances
Myelodysplastic Syndromes
Leukemia, Myeloid
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2009