bortezomib in treating patients with chronic myelogenous leukemia

Conditions: 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.

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

Keywords: relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia chronic myelogenous leukemia, bcr-abl1 positive