Palliative Care Study in Patients With Advanced Cancer

Stopped early · Phase 2

Conditions studied: Cancer

In brief

The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some patients receive AVR118, and others receive placebo (an injection expected to have no benefits). After three weeks, all patients will be offered the opportunity to take injections of AVR118.

Key facts

Study ID

NCT00127517

Run by

Advanced Viral Research Corp

Starts

2005-03-01

Expected to finish

2006-08-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• · 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.

You may not qualify if…

• · 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.

Where it is running

• Medical Center of Vincennes — Vincennes, Indiana, United States
• Queens Medical Associates — Fresh Meadows, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.