A Phase II Double Blind, Placebo Controlled, Randomized, > Multicenter Study With AVR118 Solution in Patients With Advanced > Malignancies Who Are Not Candidates for Curative Chemotherapy.

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.