Lymphoma
Conditions
Keywords
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
Brief summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.
Detailed description
OBJECTIVES: * Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma. * Determine the toxicity of this drug in these patients. * Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients. * Determine the time to progression and response duration in patients treated with this drug. OUTLINE: This is a nonrandomized, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR. Patients are followed at 4 weeks and then every 3 months until disease progression. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.
Interventions
DRUGbortezomib
Sponsors
NCIC Clinical Trials Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
Canada
Outcome results
None listed