 - Patients must not have any serious or unstable pre-existing medical conditions aside from malignancy exceptions specified above, including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation international normalized ratio INR 1.5 and partial thromboplastin time PTT within 1.1 x ULN, or psychiatric illnesssocial situations that would limit compliance with study requirements, interfere with subjects safety, or obtaining informed consent 