Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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 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.


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: - 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


NCT ID:

NCT00023881


Primary Contact:

Study Chair
Jorge Cortes, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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