|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
| 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. |
| Study Start Date: | March 2005 |
| Study Completion Date: | August 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
More Information
| 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 |
|
Oncology Palliative Care Advanced Cancer Palliative Cancer Care |