NCT01099631

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer of the Liver
• Liver Cancer
• Hepatoma
• Liver Neoplasms
• Biliary Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Salmonella typhimurium	Attenuated Salmonella typhimurium (virulent strain x4550) will be given orally in escalating dose groups: Level 1 = 10\^5, Level 2 = 10\^6, Level 3 = 10\^7, Level 4 = 10\^8, Level 5 = 10\^9, Level 6 = 10\^10.

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-01-01
• Completion: 2014-06-01
• First posted: 2010-04-07
• Last updated: 2020-07-20
• Results posted: 2020-07-20

Locations

1 site across 1 country: United States