Clinical Trial: Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers

This study is no longer recruiting patients.

Sponsors and Collaborators: University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
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
 Drug: bevacizumab
 Drug: cytarabine
 Drug: mitoxantrone
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: growth factor antagonist therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Anemia;   Bone Marrow Diseases;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bevacizumab, Cytarabine, and Mitoxantrone in Patients With Poor-Risk Hematologic Malignancies

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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:

Chemotherapy:

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:


Location Information


Georgia
      Blood and Marrow Transplant Group of Georgia, Atlanta,  Georgia,  30342-1601,  United States

Maryland
      Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States

Study chairs or principal investigators

Judith E. Karp, MD,  Study Chair,  University of Maryland Greenebaum Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068576; MSGCC-0076; NCI-2490
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00015951
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources