epratuzumab in treating patients with non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: randomized phase ii trial to study the effectiveness of epratuzumab in treating patients who have non-hodgkin's lymphoma.

objectives: * determine the response rate of patients with diffuse large b-cell non-hodgkin's lymphoma treated with epratuzumab. * determine the toxicity of this drug in these patients. outline: this is a randomized, multicenter study. patients are randomized to 1 of 3 treatment arms. * arm i: patients receive low-dose epratuzumab iv over 1 hour once weekly for 4 weeks. * arm ii: patients receive low-dose epratuzumab iv over 1 hour once weekly for 8 weeks. * arm iii: patients receive high-dose epratuzumab iv over 1 hour once weekly for 4 weeks. patients are followed every 3 months for 2 years and then every 6 months thereafter. projected accrual: a total of 150 patients (50 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed diffuse large b-cell non-hodgkin's lymphoma (nhl) * relapsed or refractory after at least 1 regimen of standard therapy * prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (asct) or immunotherapy * bidimensionally measurable disease * at least 1 lesion at least 1.5 cm by ct scan * no primary or secondary cns lymphoma * no hiv-related lymphoma * no known or suspected transformed lymphoma (prior or concurrent) * no bulky disease (i.e., any single mass greater than 10.0 cm) * no pleural effusion with positive cytology for lymphoma * most recent pathology specimen available for collection * no rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction) patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 4 months hematopoietic * absolute neutrophil count at least 1,000/mm3 * platelet count at least 50,000/mm3 (transfusion independent) * hemoglobin at least 9.0 g/dl hepatic * bilirubin no greater than 2 times upper limit of normal (uln) * ast and alt less than 5 times uln * hepatitis b surface antigen negative * hepatitis c negative renal * creatinine no greater than 2 times uln other * hiv negative * no other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage i prostate cancer * no other serious nonmalignant condition that would preclude study * no serious infection * no known human antichimeric antibodies or human antihuman antibody positivity * no type 1 hypersensitivity or anaphylactic reactions to murine proteins * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 6 months after study prior concurrent therapy: biologic therapy * see disease characteristics * at least 4 weeks since prior immunotherapy (unless clearly progressing) * at least 12 weeks since prior asct chemotherapy * see disease characteristics * at least 4 weeks since prior chemotherapy (unless clearly progressing) endocrine therapy * not specified radiotherapy * no prior radioimmunotherapy surgery * at least 4 weeks since prior major surgery (unless patient has fully recovered) other * at least 30 days since prior enrollment in clinical trials involving investigational devices or drugs * no concurrent enrollment in other clinical trials involving investigational devices or drugs * no concurrent investigational agents for disease other than nhl

Keywords: recurrent adult diffuse large cell lymphoma