IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread
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|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|
|Actual Primary Completion Date :||January 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|