Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

Phase 2TerminatedNCT00023881

M.D. Anderson Cancer Center7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

bortezomibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson Cancer Center at University of Texas

Houston, Texas, United States

Data from ClinicalTrials.gov

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