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IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread

Liver Cancer Clinical Trial

Official title:
A Phase 1 Study of an IL-2 Expressing, Attenuated Salmonella Typhimurium in Patients With Unresectable Hepatic Spread From Any Non-Hematologic Primary

Clinical Trial Summary

The working hypothesis is that oral administration of an attenuated strain of Salmonella typhimurium is safe and efficacious for patients with unresectable hepatic metastasis from a solid tumor cancer. The primary objective of the study is to determine the MTD of Salmonella typhimurium in the treatment.

Clinical Trial Description

This phase I study will be done to evaluate a dose escalation scheme of oral administration of an attenuated strain of Salmonella typhimurium expressing human interleukin-2 (IL-2) in patients with unresectable hepatic metastases from a solid tumor cancer. Standard Phase I dose escalation scheme will be used to determine the MTD of Salmonella Typhimurium. Six dose levels of Salmonella will be studied with a minimum of 3 patients enrolled in a dose level. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01099631
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact
Status Completed
Phase Phase 1
Start date April 2010
Completion date June 2014
View Details
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