Palliative Care Study in Patients With Advanced Cancer

NCT00127517 | Terminated Phase 2

• 1 other identifier: AVR118 04-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Cancer

Keywords

Oncology; Palliative Care; Advanced Cancer; Palliative Cancer Care

Interventions

peptide-nucleic acid solution AVR118 DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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

You may not qualify if:

• · 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.

Sponsors & Collaborators

• Advanced Viral Research Corp: lead

Study Sites (3)

Medical Center of Vincennes

Vincennes, Indiana, 47591, United States

Location

Queens Medical Associates

Fresh Meadows, New York, 11365, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 5, 2005
• First Posted: August 8, 2005
• Study Start: March 1, 2005
• Study Completion: August 1, 2006
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (3)