Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

Date de début de l'étude : 1 novembre 1999

DISEASE CHARACTERISTICS: Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR at least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present Measurable or evaluable disease Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only) Not eligible for curative conventional therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Platelet count at least 75,000/mm3 Bilirubin less than 2.5 mg/dL SGOT less than 3 times upper limit of normal Creatinine less than 2.0 mg/dL No New York Heart Association class III or IV heart disease No clinically significant pulmonary disease No active serious infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: At least 4 weeks since prior interferon Concurrent transfusions allowed At least 4 weeks since prior cytotoxic chemotherapy No concurrent antineoplastic agents At least 4 weeks since prior corticosteroids No concurrent glucocorticoids At least 4 weeks since prior radiotherapy