Clinical trial NCT00023881: Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Official title: Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia
Keywords: relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center at University of Texas
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jorge Cortes, MD
role: STUDY_CHAIR
References: