- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00127517
Palliative Care Study in Patients With Advanced Cancer
June 6, 2011 updated by: Advanced Viral Research Corp
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.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Vincennes, Indiana, United States, 47591
- Medical Center of Vincennes
-
-
New York
-
Fresh Meadows, New York, United States, 11365
- Queens Medical Associates
-
The Bronx, New York, United States, 10461
- Jacobi Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
August 5, 2005
First Submitted That Met QC Criteria
August 5, 2005
First Posted (Estimate)
August 8, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- AVR118 04-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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