Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
- Conditions
- Lymphoma
- Registration Number
- NCT00045695
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate 4 years 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
- Secondary Outcome Measures
Name Time Method Toxicity 4 years 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.
Cytogenetics and genome profiling 4 years To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
Trial Locations
- Locations (12)
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Abramson Cancer Center at the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada