IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread
|ClinicalTrials.gov Identifier: NCT01099631|
Recruitment Status : Completed
First Posted : April 7, 2010
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Liver Liver Cancer Hepatoma Liver Neoplasms Biliary Cancer||Biological: Salmonella typhimurium||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2010|
|Primary Completion Date :||January 2014|
|Study Completion Date :||June 2014|
Experimental: Treatment with Salmonella typhimurium
Patients will receive (a minimum of 3 patients) escalating doses of Salmonella typhimurium to achieve a maximum tolerated dose (MTD).
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.
- Maximum Tolerated Dose (MTD) of Samonella typhimurium [ Time Frame: Up to 24 Weeks After Dose of Samonella typhimurium ]Maximum tolerated dose will be determined by the number of patients with Dose limiting toxicity (DLT) at a given dose level. DLT is defined as treatment related: Sepsis (salmonella) syndrome, Grade 4 vomiting or diarrhea, Other grade 3 or greater toxicity. If > or = 2 patients at a dose level has a DLT, this level will be declared the MTD.
- Efficacy of Salmonella typhimurium in Treating Unresectable Hepatic Metastases [ Time Frame: 8 Weeks After Treatment with Salmonella typhir ]Evaluation is performed using Response Evaluation Criteria in Solid Tumors (RECIST). Each patient will be assigned one of the following categories: Complete response (CR) the disappearance of all target lesion; Partial response (PR) at least a 30% decrease; Progressive disease (PD) at least a 20% increase, or the appearance of one or more new lesions; Stable disease (SD) neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; early death from malignant disease; unknown (insufficient evaluation to determine response status).
- IL-2 Effect of Immune Function [ Time Frame: Baseline and 4 Weeks After Dosing with Salmonella typhimurium ]The in-vivo (within the living body) production of IL-2 and its effect on immune function will be tested using peripheral blood lymphocytes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099631
|United States, Minnesota|
|Edward W. Greeno, MD|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Edward W. Greeno, MD||Masonic Cancer Center, University of Minnesota|