Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Advanced Viral Research Corp |
---|---|
Information provided by: | Advanced Viral Research Corp |
ClinicalTrials.gov Identifier: | NCT00127517 |
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 |
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 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | August 2005 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carol L Epstein, MD | 617-374-6500 ext 102 | cepstein@medivector.com |
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 |
Principal Investigator: | James D'Olimpio, MD | North Shore University Hospital |
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 |
Oncology Palliative Care Advanced Cancer Palliative Cancer Care |