- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045695
Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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-
-
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Illinois
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Hinsdale, Illinois, United States, 60521
- Hinsdale Hematology Oncology Associates
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4283
- Abramson Cancer Center at the University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
- Newly diagnosed or untreated with IgM ≥ 20 g/L OR
- Previously treated with IgM ≥ 5 g/L
- Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
Must have 1 or more of the following:
- Symptomatic lymphadenopathy
- Hepatomegaly and/or splenomegaly
- Anemia (i.e., hemoglobin < 11.0 g/dL)
- Hyperviscosity syndrome
- No other lymphoproliferative disease including transformed aggressive lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- See Disease Characteristics
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- No uncontrolled bacterial, fungal, or viral infection
- No pre-existing sensory or motor neurotoxicity grade 2 or greater
- No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
- No other serious illness or medical condition that would preclude study participation
- No unreasonable geographical limitations
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- See Disease Characteristics
- At least 12 weeks since prior rituximab (for patients who have progressed)
- At least 24 weeks since prior rituximab (for patients who have not progressed)
- No prior high-dose chemotherapy and stem cell transplantation
- No prior radioactive monoclonal antibodies
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No more than 2 prior chemotherapy regimens
- The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
- Single-agent rituximab not considered 1 prior regimen
- No concurrent cytotoxic chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- At least 4 weeks since prior major surgery
Other
- At least 4 weeks since prior plasmapheresis
- At least 4 weeks since prior investigational anticancer therapy
- No other concurrent investigational anticancer agents or therapies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 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
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: 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.
|
4 years
|
Cytogenetics and genome profiling
Time Frame: 4 years
|
To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Christine I. Chen, MD, Princess Margaret Hospital, Canada
Publications and helpful links
General Publications
- Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12.
- Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Waldenstrom Macroglobulinemia
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- I152
- CAN-NCIC-IND152
- ECOG-JI152
- NCI-NCIC-152
- CDR0000257042 (Other Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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