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Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia - Article


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Idarubicin

Idamycin



Clinical Trial: Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia.

PURPOSE: This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia.

Condition Treatment or Intervention Phase
blastic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
 Drug: bevacizumab
 Drug: cytarabine
 Drug: idarubicin
 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:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bevacizumab, Idarubicin, and Cytarabine in Patients With Blastic Phase Chronic Myelogenous Leukemia

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 20-60 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML), defined by 1 of the following:
  • At least 30% blasts in peripheral blood and/or bone marrow
  • Presence of extramedullary disease

PATIENT CHARACTERISTICS: Age:

  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • No prior coagulopathies

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • INR less than 2
  • PTT no greater than 60 seconds

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No nephrotic syndrome

Cardiovascular:

  • No uncontrolled hypertension
  • No New York Heart Association class II-IV heart disease
  • No prior thrombotic events
  • LVEF ≥ 50%

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Prior imatinib mesylate allowed
  • At least 10 days since prior anticoagulants
  • No concurrent anticoagulants

Location Information


Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Jorge Cortes, MD,  Study Chair,  M.D. Anderson Cancer Center   

More Information

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

Study ID Numbers:  CDR0000068876; MDA-ID-00323; NCI-2431
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00023920
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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November 18, 2008



Page Updated: June 1, 2005
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