| Exclusion Criteria: | 1) Primary central nervous system (CNS) tumors, including primary CNS lymphoma
2) Hematological malignancies, other than peripheral Hodgkin's and non-Hodgkin's lymphomas
3) Previous hematopoietic stem cell transplant
4) Involvement of > 50% of non-Hodgkin lymphoma or Hodgkin lymphoma in the bone marrow and/or evidence of features of myelodysplasia in the bone marrow
5) Unresolved hematological toxicities > grade 1 with the exception of grade 2 lymphopenia and non-hematological toxicities > grade 1 from prior anti-cancer therapy, excluding alopecia
6) Presence of untreated or symptomatic central nervous system metastases or symptoms of brain metastases
7) Presence of ascites or pleural effusion requiring medical intervention
8) Myocardial infarction within 1 year of study Day 1, or unstable or uncontrolled disease/condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association > class II, uncontrolled hypertension [diastolic > 90 mmHg; systolic >150 mmHg]
9) Cardiac arrhythmia or CTCAE grade >/= 2 or ECG abnormalities
10) History of arterial or venous (deep vein) thrombosis within 1 year of study Day 1
11) History of bleeding diathesis
12) Known positive test for human immunodeficiency virus infection, hepatitis C virus, or chronic active hepatitis B infection.
13) Major surgery within 1 month of study Day 1
14) Unable to tolerate intravenous administration
15) Known sensitivity to mammalian derived products
16) Absolute neutrophils count (ANC) < 1.5 x 10^9/L (without granulocyte-colony stimulating factor support within 2 weeks of study Day 1; platelet count < 100 x 10^9/L (without transfusion within 2 weeks of study Day 1); or hemoglobin < 9 g/dL (without transfusion within 4 weeks of study Day 1); or PT/PTT > 1.5 x institutional upper limit of normal (ULN).
17) Estimate of glomerular filtration rate (GFR) < 60 mL/min by Cockroft and Gault equation or by 24-hour urine collections at the discretion of the PI
18) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x ULN
19) Total bilirubin, amylase or lipase > 1.5 ULN
20) Urinary protein excretion of greater than 100 mg per day (2+, 3+, or 4+ using dipstick analysis)
21) Concurrent antitumor treatment or chemotherapy, radiotherapy and hormonal therapy, except Lupron for prostate cancer and SERMS for breast cancer subjects, within 4 weeks (6 weeks for nitrosoureas or mitomycin) of study Day 1
22) Antibody therapy for the treatment of underlying malignancy within 4 weeks prior to study Day 1, with the exception of bevacizumab (AvastinŽ) and other monoclonal antibodies with a half- life of greater than 10 days which, must be discontinued at least 8 weeks prior to study Day 1.
23) Investigational agent within 30 days of study Day 1
24) Any elective surgeries scheduled during their participation in the study, and through 28 days after their last administration of AMG 655
25) Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy (low-dose warfarin (< 2 mg/day) for prophylaxis against central venous catheter thrombosis is allowed)
26) Concurrent use of herbal medications
27) Concurrent immunosuppressant therapy (cyclosporine A, FK506, etc., or chronic > 5mg/d of prednisone)
28) Other investigational procedures are excluded
29) Subject who is pregnant (e.g., positive human choriogonadotropin test) or breastfeeding
30) Subject of childbearing potential, or subject who has a partner of childbearing potential, is not using adequate contraceptive precautions
31) Subject will not be available for follow-up assessment
32) Subject has any kind of disorder that compromises the ability of the subjects to given written informed consent and/or comply with study procedures
33) Any co-morbid medical condition that would increase the risk of toxicity (in the opinion of the investigator or sponsor)
34) Subject has known sensitivity to any of the products to be administered during dosing |