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PI transferred to another institution and did not take this study with him.
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The purpose of this study is to see how well electrochemotherapy works at treating people with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines electroporation and chemotherapy administration. Electroporation uses an electric current to produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher concentration of administered chemotherapy agent. This study will test the safety and look at the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma. This study will also help to find the safest and most effective amount of electroporation voltage to apply to this type of tumor.
This is a phase I dose escalation trial using a 3 + 3 dose escalation scheme to evaluate the maximum tolerated field strength dose of administered irreversible electroporation in combination with chemotherapy. During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with FOLFIRINOX. The schedule of administration of FOLFIRINOX will be administered as per standard of care. The investigators will use non-invasive dynamic magnetic resonance imaging and magnetic resonance spectroscopy to detect and describe changes within the tumor. Safety will be determined by assessing the number of class three or higher toxicity events in cohorts of 6 patients at progressively higher electroporation voltages. The maximum tolerated dose (MTD) will be defined as one voltage level less than the voltage at which two or more patients out of six total patients have a class three or higher toxicity event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrochemotherapy with FOLFIRINOX | Experimental | During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with FOLFIRINOX . The schedule of administration of FOLFIRINOX will be administered as per standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRINOX | Drug | The chemotherapy schedule will include administration of FOLFIRINOX (5-Fluorouracil, Irinotecan, Oxaliplatin, and Leucovorin) will be: Day 1: Oxaliplatin at 85mg/m2 over 120 minutes, Irinotecan 180mg/m2 over 90 minutes, Leucovorin 400mg/m2 over 90minutes, 5-Fluorouracil (5-FU) 1200mg/m2/day continuous infusion (CIV) over 46 hours. Day 3: 5-FU CIV pump will be disconnected. Neulasta injection 6mg subcutaneous |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced dose limiting toxicities (DLTs) | A dose limiting toxicity (DLT) is any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) that is possibly related to the electrochemotherapy treatment. CTCAE 4.0 Grade 3 is a severe AE and Grade 4 is a life-threatening or disabling AE. DLTs are collected to determine the Maximum Tolerated Dose (MTD), which is defined as as one field strength level less than the field strength at which two or more patients out of six total patients experience a DLT. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by time to progression | Time to progression is the time after treatment until tumor enlargement or metastatic disease is identified. | 1 year |
| Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by one year survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek L West, MD, MS | The University of Texas Health Science Center, Houston | Principal Investigator |
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| ID | Term |
|---|---|
| C000627770 | folfirinox |
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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| Electroporation | Device | Irreversible electroporation (IRE) will be performed under computed tomography (CT) guidance, during which 2 to 6 needles are advanced into the pancreatic tumor where a specified field strength will be applied. |
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One year survival is the number of patients who are alive one year after treatment. |
| 1 year |
| Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by tumor imaging | We will assess tumor size changes and tumor staging through magnetic resonance imaging (MRI). | 1 year |
| Number of participants who demonstrated diffusion weighted magnetic resonance imaging (MRI) changes | 1 year |
| Number of participants who demonstrated magnetic resonance spectroscopy (MRS) changes | 1 year |
| Number of groups of patients who have similar pancreatic tumor gene expression characteristics after electrochemotherapy | Gene expression characteristics are identified by biopsy specimen evaluation. | 1 year |
| Number of groups of patients who have similar imaging characteristics after electrochemotherapy | Imaging characteristics are evaluated by MRI and MRS. | 1 year |
| Number of groups of patients who have similar clinical outcomes after electrochemotherapy | Clinical outcomes are evaluated by time to progression and 1 year survival. Time to progression is the time after treatment until tumor enlargement or metastatic disease is identified. One year survival is the number of patients who are alive one year after treatment. | 1 year |