Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-02

Study Completion Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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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.

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.

Conditions

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Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bortezomib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No