The purpose of this study is to determine whether patients with advanced cancers with 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.

Condition	Intervention	Phase
Palliative Cancer Care Advanced Cancer	Drug: peptide-nucleic acid solution AVR118	Phase II

Further Study Details: 

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, double blind study comparing treatment with AVR118 to placebo, followed by an open label phase treating all patients with AVR118, will enable the Sponsor to gather data on safety and efficacy of AVR118 in this patient population. Patients aged 18-80 with advanced cancers (excluding CNS cancers) who are not receiving chemotherapy, may be eligible to participate.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• • Histologically confirmed malignancy (excluding central nervous system malignancy) • Not a candidate for, or refuses, 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 >40%, < 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) >1,500/mm3. • Platelets >50,000/mm3. • 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 chemotherapy, immunotherapy, radiation therapy or experimental therapy within three weeks.

• 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. • Uncontrolled intercurrent illness or major organ failure, including, but not limited to, ongoing or active infection, pulmonary, renal, or hepatic failure, adrenal insufficiency, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

• Another serious medical or psychiatric illness that could, in the Investigator’s opinion, potentially interfere with the completion of treatment or clinical assessments according to this protocol.

• Female patient is pregnant or breast-feeding.

Please refer to this study by ClinicalTrials.gov identifier  NCT00127517

Carol L Epstein, MD      617-374-6500  Ext. 102    cepstein@medivector.com

Indiana
      Medical Center of Vincennes, Vincennes,  Indiana,  47591,  United States; Recruiting
New York
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
      Jacobi Medical Center, The Bronx,  New York,  10461,  United States; Recruiting
      Queens Medical Associates, Fresh Meadows,  New York,  11365,  United States; Recruiting

Study chairs or principal investigators

James D''''Olimpio, MD,  Principal Investigator,  North Shore University Hospital   

Study ID Numbers:  AVR118 04-002
Last Updated:  August 5, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00127517
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23