A Phase 1 interventional study of Electroporation and gemcitabine in Pancreatic Adenocarcinoma, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by The University of Texas Health Science Center, Houston · Phase 1, Interventional, and Treatment
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 gemcitabine and nab-paclitaxel. The schedule of administration of gemcitabine and nab-paclitaxel 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.
2,002 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 6 is below the median of 45 across 1,551 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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Exclusion Criteria:
During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with gemcitabine and abraxane. The schedule of administration of gemcitabine and nab-paclitaxel will be administered as per standard of care. The chemotherapy schedule will include administration of nab-paclitaxel 125mg/m2 intravenous (IV) over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000mg/m2 IV infusion over approximately 30 minutes on days 1, 8, and 15 of each 28 day cycle.
Device: Electroporation · Drug: gemcitabine · Drug: nab-paclitaxel
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.
Also known as: Irreversible electroporation (IRE)
The chemotherapy schedule will include administration of gemcitabine 1000mg/m2 IV infusion over approximately 30 minutes on days 1, 8, and 15 of each 28 day cycle.
Also known as: Gemzar
The chemotherapy schedule will include administration of nab-paclitaxel 125mg/m2 intravenous (IV) over approximately 30 to 45 minutes on Days 1, 8, and 15.
Also known as: Abraxane
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.
Time frame: 4 weeks
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.
Time frame: 1 year
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by one year survival
One year survival is the number of patients who are alive one year after treatment.
Time frame: 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).
Time frame: 1 year
Number of participants who demonstrated diffusion weighted magnetic resonance imaging (MRI) changes
Time frame: 1 year
Number of participants who demonstrated magnetic resonance spectroscopy (MRS) changes
Time frame: 1 year
Number of groups of patients who have similar pancreatic tumor gene expression characteristics and associated imaging characteristics after electrochemotherapy
Gene expression characteristics are identified by biopsy specimen evaluation. Imaging characteristics are evaluated by MRI and MRS.
Time frame: 1 year
Number of groups of patients who have similar pancreatic tumor gene expression characteristics and associated clinical outcomes after electrochemotherapy
Gene expression characteristics are identified by biopsy specimen evaluation. 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.
Time frame: 1 year
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston