 - Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Patients who are medically unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and patients whose circumstances do not permit completion of the study or the required follow-up. 