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Palliative Care Study in Patients With Advanced Cancer
This study is currently recruiting participants.
Verified by Advanced Viral Research Corp, August 2005
Sponsored by: Advanced Viral Research Corp
Information provided by: Advanced Viral Research Corp
ClinicalTrials.gov Identifier: NCT00127517
  Purpose

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.


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

MedlinePlus related topics: Cancer Palliative Care
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Double Blind, Placebo Controlled, Randomized, Multicenter Study With AVR118 Solution in Patients With Advanced Malignancies Who Are Not Candidates for Chemotherapy

Further study details as provided by Advanced Viral Research Corp:

Study Start Date: March 2005
Estimated Study Completion Date: August 2005
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, 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 central nervous system [CNS] cancers) who are not receiving chemotherapy, may be eligible to participate.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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% to < 80%.
  • Normal cognition, interpreted as a Mini-Mental State Examination 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, thyroid-stimulating hormone (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, 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 for being 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127517

Contacts
Contact: Carol L Epstein, MD 617-374-6500 ext 102 cepstein@medivector.com

Locations
United States, Indiana
Medical Center of Vincennes Recruiting
Vincennes, Indiana, United States, 47591
Contact: Marybeth Wagoner, RN     812-885-0680     marybethw@charterinternet.com    
Principal Investigator: Donald Fleming, MD            
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: James D'Olimpio, MD     516-562-8906     jdolimpi@nshs.edu    
Principal Investigator: James D'Olimpio, MD            
Jacobi Medical Center Recruiting
The Bronx, New York, United States, 10461
Contact: Bola Omotosho, MD     718-918-6137     remibola@aol.com    
Principal Investigator: Manuel Macapinlac, MD            
Queens Medical Associates Recruiting
Fresh Meadows, New York, United States, 11365
Contact: Lisa Lewis     718-460-2300        
Principal Investigator: Barry Kaplan, MD            
Sponsors and Collaborators
Advanced Viral Research Corp
Investigators
Principal Investigator: James D'Olimpio, MD North Shore University Hospital
  More Information

Study ID Numbers: AVR118 04-002
Study First Received: August 5, 2005
Last Updated: August 23, 2005
ClinicalTrials.gov Identifier: NCT00127517  
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Viral Research Corp:
Oncology
Palliative Care
Advanced Cancer
Palliative Cancer Care

ClinicalTrials.gov processed this record on January 16, 2009