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Home > "B" Clinical Trials Conditions > Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia  Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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. 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 phasechronic myelogenous leukemia. PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with idarubicin and cytarabine in treating patients who have blast phase chronic myelogenous leukemia.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JorgeCortes, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Jorge Cortes 713-794-5783
Additional Information:
Study ID Numbers: CDR0000068876; NCI-2431,MDA-ID-00323
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023920
Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
2. Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
3. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
4. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
5. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
Related Studies:
Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
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