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Brief Title: Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features
Official Title: Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features
Study ID: NCT00314925
Brief Summary: The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Centers of Florida, Ocoee, Florida, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
New York Oncology Hematology P.C., Albany, New York, United States
Dayton Oncology & Hematology, P.A ., Kettering, Ohio, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Mary Crowley Research Center, Dallas, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Northwest Cancer Specialists - Vancouver Cancer Center, Vancouver, Washington, United States
Name: Rudin Charles, MD, PhD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR