Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01099631 · ClinicalTrials.gov registry record · Phase 1
IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread
A Phase 1 study of Liver Cancer and Liver Neoplasms, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT01099631: Completed Phase 1 study of Liver Cancer and Liver Neoplasms, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01099631 is a Phase 1 study of Liver Cancer and Liver Neoplasms that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 22 participants, below the 448-participant average among 78 other Liver Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01099631, a Phase 1 study of Liver Cancer and Liver Neoplasms, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Salmonella typhimurium
Study Locations (1)
Minnesota
- Edward W. Greeno, MD - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01099631 record still lists
NCT01099631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 448-participant average among 78 other Liver Cancer trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Liver Cancer appearing as the primary indexed condition, and to 1 intervention - of which Salmonella typhimurium is the first listed.
NCT01099631 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01099631 about?
NCT01099631 is a clinical study titled "IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread". 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 treatm...
What is the current status of trial NCT01099631?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2010-04. Estimated completion is 2014-06.
What conditions does trial NCT01099631 study?
This clinical trial studies the following conditions: Liver Cancer, Liver Neoplasms, Biliary Cancer, Hepatoma, Cancer of the Liver.
What interventions are being tested in trial NCT01099631?
The interventions under investigation include: Salmonella typhimurium (BIOLOGICAL).
Who is sponsoring clinical trial NCT01099631?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01099631 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Liver Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01099631's enrollment target sits among peer trials
22 58th of 78 higher than 19 of 78 other Liver Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
RECRUITING · Phase 1
-
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
RECRUITING · Phase 1
-
Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
RECRUITING · Phase 1
-
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Patients With Pediatric Solid Tumors (GAP)
ACTIVE NOT RECRUITING · Phase 1
-
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia