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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045695 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia |
Study Start Date: | August 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
Must have 1 or more of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior chemotherapy regimens
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Hinsdale Hematology Oncology Associates | |
Hinsdale, Illinois, United States, 60521 | |
United States, Pennsylvania | |
Abramson Cancer Center at the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Centre - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, Manitoba | |
CancerCare Manitoba | |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Canada, Quebec | |
Maisonneuve-Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 | |
Canada, Saskatchewan | |
Saskatoon Cancer Centre | |
Saskatoon, Saskatchewan, Canada, S7N 4H4 |
Study Chair: | Christine I. Chen, MD | Princess Margaret Hospital, Canada |
Investigator: | Edward A. Stadtmauer, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000257042, CAN-NCIC-IND152, ECOG-JI152, NCI-NCIC-152 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045695 |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders |
Lymphatic Diseases Waldenstrom Macroglobulinemia Hemorrhagic Disorders Waldenstrom macroglobulinemia Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |