Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma

Exclusion Criteria

• •Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C)
• •Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment
• •Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment
• •Previous exposure to IDEC-114 or any anti-CD80 antibody
• •ABMT within 6 months prior to first scheduled treatment
• •Abnormal liver function
• •Abnormal renal function
• •Presence of chronic lymphocytic leukemia (CLL)
• •Presence of CNS lymphoma
• •Presence of HIV infection or AIDS
• •Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma
• •Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
• •Serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor
• •New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment
• •Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment
• •Pleural invasion and/or effusion with positive cytology for lymphoma
• •Peritoneal invasion and/or ascites with positive cytology for lymphoma