Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase

Conditions
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Leukemia

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive