Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Waldenstrom macroglobulinemia
Eligibility Criteria
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
Sites / Locations
- Hinsdale Hematology Oncology Associates
- Abramson Cancer Center at the University of Pennsylvania
- Tom Baker Cancer Centre - Calgary
- Cross Cancer Institute
- CancerCare Manitoba
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
- Margaret and Charles Juravinski Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Toronto Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- Maisonneuve-Rosemont Hospital
- Saskatoon Cancer Centre