Clinical Trial: Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Neotropix

Current Primary Outcome: Incidence of dose-limiting toxicity and determination of phase II dose [ Time Frame: Within 28 days of treatment administration ]

Original Primary Outcome:

  • Incidence of dose-limiting toxicity within 28 days of treatment administration
  • Determination of phase II dose


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Number of responses according to RECIST criteria
  • Limited pharmacokinetics
  • Limited biodistribution and elimination
  • Limited evaluation of occurrence of neutralizing antibody


Information By: Neotropix

Dates:
Date Received: April 13, 2006
Date Started: April 2006
Date Completion: December 2008
Last Updated: February 23, 2010
Last Verified: February 2010