Patient case: 4-year-old female with leukemia; genetic feature: ABL1

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.

Detailed 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: 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

Relevance to patient case: not relevant