Lymphoma
Conditions
Keywords
recurrent adult diffuse large cell lymphoma
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States