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Bortezomib in Treating Patients With Chronic Myelogenous Leukemia



Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

For Condition: accelerated phase chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase.
Details: OBJECTIVES: - Determine the efficacy of bortezomib, in terms of response rate, duration of response, and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase. - Assess the toxicity of this drug in these patients. OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) in chronic or accelerated phase, defined as having any of the following: - Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30% - PB or BM blasts and promyelocytes at least 20% - PB or BM basophils at least 20% - Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart or 50% increase in splenomegaly over 4 weeks) - Clonal evolution defined as the presence of additional cytogenetic abnormalities other than the Ph chromosome - Thrombocytopenia (platelet count less than 100,000/mm^3) unrelated to therapy - Hemoglobin less than 7 g/dL unrelated to therapy or bleeding - Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to receive it - Ineligible for higher-priority or higher-efficacy regimens or protocols - No blastic phase CML PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 18 weeks Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Other: - No other concurrent illness that would preclude study entry - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or hydroxyurea - At least 4 weeks since prior chemotherapy and recovered - Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - See Disease Characteristics - See Chemotherapy - At least 24 hours since prior imatinib mesylate - No other concurrent investigational agents
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:  CDR0000068872;  MDA-DM-00274,NCI-1756
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023881

Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

2. Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia

3. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies

4. Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

5. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

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