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.