Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT lymphoma Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL Progression of disease or no response since last treatment for NHL 1D10+ lymphoma by immunohistochemistry or flow cytometry Bidimensionally measurable disease at least 2 cm in a single dimension No CNS metastases Circulating tumor cells no greater than 5,000/mm^3 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 75,000/mm^3 (unless disease related) Neutrophil count at least 1,000/mm^3 (unless disease related) Hemoglobin greater than 8.0 g/dL Hepatic: Bilirubin less than 2.5 mg/dL SGOT less than 4 times upper limit of normal Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No clinically significant cardiac disease (New York Heart Association class III or IV) No evidence of myocardial infarction or cardiac arrhythmia (unless surgically repaired) within the past 6 months Pulmonary: No clinically significant pulmonary disease Other: No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ No significant psychiatric or CNS impairment No active serious infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study Negative anti-Hu1D10 antibody response (HAHA/HAMA) HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior interferon therapy At least 3 months since prior immunotherapy No prior monoclonal antibody Hu1D10 Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day) No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing diseases or adverse reactions Radiotherapy: See Disease Characteristics At least 4 weeks since prior external beam radiotherapy At least 3 months since prior radioimmunotherapy Surgery: Not specified Other: No other concurrent lymphoma therapy
Sites / Locations
- Protein Design Labs, Inc.