CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Salmonella typhimuriumbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01099631
NCT01099631Phase 1Completed
CompareCT.gov

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

Masonic Cancer Center, University of Minnesota·interventional·Posted Apr 7, 2010·Updated Jul 20, 2020

In Brief

A Phase 1 clinical trial evaluating Salmonella typhimurium for Cancer of the Liver and 4 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of the Liver, Liver Cancer, Hepatoma, Liver Neoplasms, Biliary Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2010
Enrollment StartApr 1, 2010
Primary CompletionJan 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.2 years ago

Interventions

Salmonella typhimuriumbiological

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.