| Exclusion Criteria: | 1) Patients received antibody therapy within the time period as described below, and/or have not fully recovered from the toxic effects of that treatment: (1) Alemtuzumab (Campath®) within 6 months prior to the first dose of HCD122 (CHIR-12.12), (2) Rituximab (Rituxan®) within 60 days prior to the first dose of HCD122 (CHIR-12.12), (3) Any other monoclonal antibody within 90 days prior to the first dose of HCD122 (CHIR-12.12)
2) History of another primary malignancy that is currently clinically significant, has the potential for metastases or currently requires active intervention
3) Impaired cardiac function or clinically significant cardiac disease, including any one of the following: (1) New York Heart Association Class III or IV cardiac disease, including preexisting arrhythmia, congestive heart failure, or cardiomyopathy (2) Angina pectoris </= 3 months prior to starting study drug (3) Acute MI </= 3 months prior to starting study drug (4) Other clinically significant heart disease (e.g., uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
4) Clinically significant pulmonary dysfunction requiring oxygen therapy; for any patient with a history of serious pulmonary disease, FEV(subscript)1 and DL (subscript)CO must be > 55% predicted within 8 weeks of enrollment
5) History of pulmonary embolism
6) History of deep vein or other thrombosis with the exception of catheter thrombosis; patients with an intravenous catheter must be treated with a low dose prophylactic anticoagulant to prevent catheter thrombosis
7) History of active infection (viral, bacterial, or fungal) requiring systemic therapy within 4 weeks of enrollment
8) Prior allogeneic stem cell transplant
9) Active autoimmune disease requiring imunosuppressive therapy
10) Known positive serology for human immunodeficiency virus (HIV)
11) Known current drug or alcohol abuse
12) Other severe, acute, or chronic medical or phychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for this study
13) Prior anaphylactic reaction to human immunoglobulin administration
14) History of pancreatic disease (e.g., acute or chronic pancreatitis, etc.) or any surgery of the pancreas
15) Women of child-bearing potential (WCBP) who are pregnant or breast feeding. WCBP defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months must have a negative serum pregnancy test </= 72 hours prior to starting study treatment. In addition, all sexually active WCBP and male patients must agree to use adequate contraceptive methods throughout the study.
16) Any abnormality on the baseline CT scan that potentially is associated with an increased risk of developing a pancreatitis or an increase in serum amylase and/or lipase (e.g., gallbladder stones).
17) Cystic fibrosis or any other risk factors that may contribute to the development of pancreatitis. |