Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Proteasome Inhibitors

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