Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features
This is the first study in man of Seneca Valley Virus, a virus which seeks and kills certain
tumors in non-human model systems. Subjects in this trial will be patients with advanced
cancer displaying certain specified neuroendocrine features, pathologically; they will have
exhausted standard methods of treatment for their tumor. The primary purpose of the trial is
to determine if the virus may be administered safely. Additional purposes are to learn
about the distribution of the virus in the body, the elimination of the virus from the body,
the immune response to the virus and whether the virus might have some beneficial effects
upon the tumors which the patients have. The first patients will be treated with low amounts
of virus and subsequent patients may receive higher amounts. At the end of the trial, it is
intended to select a dose for further study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of dose-limiting toxicity and determination of phase II dose
Within 28 days of treatment administration
Yes
Rudin Charles, MD, PhD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
N05-10564
NCT00314925
April 2006
December 2008
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Tyler Cancer Center | Tyler, Texas 75702 |
Cancer Centers of Florida | Orlando, Florida 32806 |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Mary Crowley Research Center | Dallas, Texas 75246 |
New York Oncology Hematology P.C. | Albany, New York 12208 |
Dayton Oncology & Hematology, P.A . | Kettering, Ohio 45409 |
Northwest Cancer Specialists - Vancouver Cancer Center | Vancouver, Washington 98684 |