Status:
TERMINATED
Palliative Care Study in Patients With Advanced Cancer
Lead Sponsor:
Advanced Viral Research Corp
Conditions:
Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Advanced cancers are usually debilitating. There are few treatments available for symptoms of advanced cancers like loss of appetite, decreased strength, fatigue, and change in mood. A Phase II, doubl...
Eligibility Criteria
Inclusion
- · 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
- · 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00127517
Start Date
March 1 2005
End Date
August 1 2006
Last Update
June 8 2011
Active Locations (3)
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1
Medical Center of Vincennes
Vincennes, Indiana, United States, 47591
2
Queens Medical Associates
Fresh Meadows, New York, United States, 11365
3
Jacobi Medical Center
The Bronx, New York, United States, 10461