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Palliative Care Study in Patients With Advanced Cancer

This study has been terminated.
(Company shifted focus)
Sponsor:
Information provided by:
Advanced Viral Research Corp
ClinicalTrials.gov Identifier:
NCT00127517
First received: August 5, 2005
Last updated: June 6, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Curative Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Advanced Viral Research Corp:

Study Start Date: March 2005
Study Completion Date: August 2006
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, or who are receiving single agent, third line (or beyond) 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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127517

Locations
United States, Indiana
Medical Center of Vincennes
Vincennes, Indiana, United States, 47591
United States, New York
Queens Medical Associates
Fresh Meadows, New York, United States, 11365
Jacobi Medical Center
The Bronx, New York, United States, 10461
Sponsors and Collaborators
Advanced Viral Research Corp
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127517     History of Changes
Other Study ID Numbers: AVR118 04-002
Study First Received: August 5, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014