RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.
OBJECTIVES: * Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia. * Determine the toxicity of this drug in these patients. * Determine the time to progression, stable disease duration, and response duration in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
PS-341 bolus intravenous injection twice weekly\* for 2 out of every 3 weeks
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Response rate
To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia
Time frame: 4 years
Toxicity
To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
Time frame: 4 years
Cytogenetics and genome profiling
To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
Time frame: 4 years
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Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
...and 2 more locations