Bortezomib in Treating Patients With Mantle Cell Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy At least 1 bidimensionally measurable disease site* Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: *Bone lesions are not considered bidimensionally measurable disease No pre-existing ascites or pleural effusion No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular LVEF at least 45% by echocardiogram or MUGA Pulmonary No pre-existing shortness of breath greater than grade 1 Other: No uncontrolled bacterial, fungal, or viral infections No pre-existing edema greater than grade 1 No pre-existing neuropathy greater than grade 1 No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix No other serious illness or medical condition that would preclude study compliance No geographical conditions that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Prior rituximab allowed No prior radioactive monoclonal antibody therapy Chemotherapy: See Disease Characteristics No prior high-dose chemotherapy with stem cell transplantation No more than 2 prior systemic chemotherapy regimens Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens No prior flavopiridol At least 6 weeks since prior chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to 25% or more of functioning bone marrow At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered No concurrent radiotherapy to the sole site of measurable disease Surgery: At least 2 weeks since prior major surgery Other: No prior investigational therapy No other concurrent anticancer therapy No other concurrent investigational anticancer therapy
Sites / Locations
- Cross Cancer Institute
- British Columbia Cancer Agency
- CancerCare Manitoba
- Margaret and Charles Juravinski Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Toronto Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- Maisonneuve-Rosemont Hospital
- McGill University