NCT00314925

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

Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Neotropix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoid
• Neuroendocrine

Interventions

Type	Name	Description
DRUG	Seneca Valley Virus (biological agent)	Dose escalation (starting at 1 × 10\^7 vp/kg), IV (in the vein) over 1 hour in a single administration

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-04-17
• Last updated: 2010-02-25

Locations

10 sites across 1 country: United States