Myeloproliferative Neoplasms Clinical Trial
Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Summary
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.
Full Description
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 intravenous (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 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:
Eastern Cooperative Oncology Group (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
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There is 1 Location for this study
Houston Texas, 77030, United States
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