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

NCT01099631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-07-20

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Edward W. Greeno, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-01-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099631 on ClinicalTrials.gov