Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

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