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

This study is ongoing, but not recruiting participants.

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
Drug: bevacizumab
Drug: cytarabine
Drug: mitoxantrone hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   Cytarabine    Cytarabine hydrochloride    Mitoxantrone hydrochloride    Mitoxantrone    Bevacizumab   

U.S. FDA Resources

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)

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
National Cancer Institute (NCI)

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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068576, MSGCC-0076, NCI-2490
First Received:   May 6, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00015951
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:
Blast Crisis
Hematologic Neoplasms
Precancerous Conditions
Chronic myelogenous leukemia
Refractory anemia
Chronic myelomonocytic leukemia
Bevacizumab
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Cytarabine
Myelodysplastic syndromes
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplasia
Anemia
Acute myelogenous leukemia
Leukemia, Myeloid
Endothelial Growth Factors
Recurrence
Antibodies
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Mitoxantrone
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Disease
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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