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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Dose escalation (starting at 1 × 10\^7 vp/kg), IV (in the vein) over 1 hour in a single administration
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
Incidence of dose-limiting toxicity and determination of phase II dose
Time frame: Within 28 days of treatment administration
Number of responses according to RECIST criteria
Time frame: Baseline; at Week 7, Day 7 following therapy and then confirmation scan at least 4 weeks later, if required; and every 2 months for up to 6 months, if required
Limited pharmacokinetics, biodistribution and elimination
Time frame: Until 2 consecutive negative viral assays
Limited evaluation of occurrence of neutralizing antibody
Time frame: Baseline and at Week 2, Day 1 following therapy
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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