Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

Leukemia Clinical Trial

Official title:

Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00023881
• Other study ID #: CDR0000068872
• Secondary ID: MDA-DM-00274NCI-
• Status: Terminated
• Phase: Phase 2
• Start date: July 2, 2001
• Est. completion date: March 2005

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,