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About
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (< 70% vs ≥ 70%), lactic dehydrogenase level (normal vs > upper limit of normal), age (18 to 60 years vs > 60 years), and lymphoma subtype (follicular vs marginal zone). Patients are randomized to 1 of 2 treatment arms.
Patients in either arm may crossover to the other arm if treatment is found to be ineffective.
Patients are followed at 30 days and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 24-66 patients (12-33 per treatment arm) will be accrued for this study within 1 year.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
CD20-positive disease
Relapsed or progressive disease after prior anti-neoplastic therapy, as indicated by 1 of the following:
Complete response ≥ 6 months in duration after prior rituximab therapy* NOTE: *For patients who were previously treated with a regimen that included rituximab
At least 1 measurable lymph node mass > 1.5 cm in 2 perpendicular dimensions that has not been irradiated OR that has progressed since prior radiotherapy
No active CNS lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
No peripheral neuropathy or neuropathic pain ≥ grade 2
No other malignancy within the past 5 years except completely resected basal cell or squamous cell skin cancer or an in situ malignancy
Previously diagnosed prostate cancer allowed provided the following criteria are met:
No serious medical or psychiatric illness that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Recovered from all prior therapy
No prior bortezomib
More than 3 weeks since prior antineoplastic therapy
More than 3 weeks since prior experimental therapy
No other concurrent antineoplastic therapy
No other concurrent investigational agents
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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