Idarubicin |
Idamycin |
Clinical Trial: Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
This study has been completed.
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
OBJECTIVES:
- Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in patients with blastic phase chronic myelogenous leukemia.
- Determine the toxicity profile of this regimen in these patients.
- Determine the effect of bevacizumab on angiogenesis in these patients.
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:
- No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis
- Prior hydroxyurea allowed
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
Jorge Cortes, MD, Study Chair, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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
Resources
- Idamycin (Drug Digest)
- Idarubicin (Drug Digest)

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