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Phase II Study of Bortezomib in Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in Chronic or Accelerated Phase
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI
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MDA-DM-00274 NCI-1756, NCT00023881, 1756
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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.
Entry 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/mm3)
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
Prior/Concurrent Therapy:
Biologic therapy: 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: Radiotherapy: - At least 4 weeks since prior radiotherapy and
recovered
Surgery: Other: - See Disease Characteristics
- See Chemotherapy
- At least 24 hours since prior imatinib mesylate
- No other concurrent investigational agents
Patient Characteristics:
Age: Performance status: Life expectancy: 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
Expected Enrollment A total of 5-30 patients will be accrued for this study within 15-30 months. 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.
Trial Contact Information
Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas | | | Jorge Cortes, MD, Protocol chair | | | |
Registry Information | | Official Title | | Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase | | Trial Start Date | | 2001-07-02 | | Registered in ClinicalTrials.gov | | NCT00023881 | | Date Submitted to PDQ | | 2001-07-10 | | Information Last Verified | | 2004-11-08 | | NCI Grant/Contract Number | | P30-CA16672, U01-CA62461 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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