Palliative Care Study in Patients With Advanced Cancer

Inclusion Criteria: * · Histologically confirmed malignancy (excluding central nervous * system malignancy) * · Not a candidate for, or refuses, curative anti-neoplastic therapy. * · Between the ages of 18 and 80. * · Symptoms of advanced cancer (loss of appetite, fatigue, weakness, * malaise) that are not attributed to anemia, concomitant illnesses, or * obstruction or loss of organ function. * · Karnofsky performance status of ³40%, \_\<\_ 80%. * · Normal cognition, interpreted as a Mini-Mental State Score of at * least 20. * · Life expectancy of \>4 months. * · Decrease in weight of at least 5% over the preceding 6 months, with * no weight gain over the most recent 30 days * · Pretreatment laboratory data within 7 days of enrollment (if * screening labs are done within 3 days of Day 1, they need not be * repeated on Day 1). * ¨ Hemoglobin \>8.5 g/dL on no, or on stable doses (hematocrit stable * within 1 gram and dose stable for one month) of Epogen or similar * medication. * ¨ Absolute neutrophil count (ANC) ³1,500/mm\^3 . * ¨ Platelets ³50,000/mm\^3 . * ¨ Total bilirubin £1.5 the upper limit of normal (ULN). * ¨ ALT and AST £2.5 times the ULN, or, if the patient has liver * metastases, £5 times the ULN. * ¨ Creatinine £1.5 mg/dL. * ¨ Fasting blood sugar -\<1.2 x ULN * ¨ Normal T3, T4, TSH * · Voluntary written informed consent before performance of any * study-related procedure that is not part of normal medical care. * · Ability to self-administer subcutaneous medication, or to have an * assistant who can administer the study medication according to the * protocol. * · Female patient is post-menopausal, surgically sterilized, or willing * to use acceptable methods of birth control (i.e., a hormonal * contraceptive, intra-uterine device, diaphragm with spermicide, or * condom with spermicide, or abstinence) for the duration of the study. * · Male patient agrees to use an acceptable barrier method for * contraception during the study. * · If on an antidepressant, the dose must have been stabilized for at * least 60 days Exclusion Criteria: * · Received immunotherapy, radiation therapy or experimental therapy * within three weeks. * · Receiving chemotherapy other than third-line, single agent therapy; * permitted third-line, single agent dose must be stable for at least * one month. * · Diabetes requiring insulin or oral hypoglycemic agents. * · Mechanical reason to be unable to eat, or is reasonably expected to * develop an obstruction during the next eight weeks * · Myocardial infarction within six months of enrollment. * · Uncontrolled brain metastases or central nervous system disease. * · Major surgery within four weeks of enrollment. * · Severe allergies to milk or milk products.