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Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VectRx Thermal Therapy
Sponsored by
NeoTherma Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provide signed and dated informed consent form Subjects who are > 18 years old Histologically or cytologically proven adenocarcinoma of the pancreas Subjects who enrolled prior to- or during initial course of planned chemotherapy. Subjects with other histology that would typically receive these regimens are included (i.e. adenosquamous) BR and UR Pancreatic Cancer based on modified NCCN guideline will be used as a guide for radiographic findings (94), or high risk resectable pancreatic cancer recommended by a multi-disciplinary team for chemotherapy based on NCCN recommendations (NCCN version 2.2021). Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT Eastern Cooperative Oncology Group (ECOG) performance of 0-1 (Appendix D) Estimated life expectancy > 9 months If female patient is of child-bearing potential, she must have a negative serum pregnancy test (βhCG) documented at screening Subjects who meet the following baseline organ function parameters: Absolute neutrophil count >/= 1,500cells/mm3 Platelets >100,000cells/mm3 Total Bilirubin ≤1.5X normal institutional limits OR < 2.0 ULN if stenting occurred AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2 Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection must meet the following criteria: HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at screening. Subjects with cured hepatitis C virus (HCV) infection at screening can be enrolled but should have HBV DNA levels checked periodically while on study to monitor for reactivation. Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab (-) HCV Ab (+) and HCV RNA (-) Exclusion Criteria: Subjects with any part of the body between the hips and shoulders >46 inch circumference, with an anterior posterior depth of ~10.5" in a supine position (fit may vary with body shape) Subjects unable to tolerate magnetic resonance imaging Subjects receiving treatment with other radiofrequency medical devices Subject has pacemaker, electrocardiograph, implanted defibrillator, infusion pumps, insulin pumps, cardiac monitoring electrodes and devices, deep brain stimulators, cochlear implants, radiofrequency identification devices attached to devices, or any implanted active electronic device or monitoring system, adhesive skin patches including conductive metal Metal biliary stents (plastic stents are allowed) Non-removable implanted designated MR unsafe and/or RF incompatible ferromagnetic metallic devices such as metal joint replacements Subjects who have ferromagnetic or electrically conductive, metal, or foreign objects in or on or attached to their body Severe pulmonary disease with a forced expiratory volume (FEV) <50% Unstable angina pectoris (under medication) with imminent threat of an infarction Myocardial infarction <6 months ago Cardiac decompensation or arrhythmia necessitating medication Systolic blood pressure >180 mmHg and/or <90 mmHg, while using medication Diastolic blood pressure >100 mmHg and/or <50 mmHg, while using medication Open skin wounds on the torso Severe cerebrovascular disease: multiple cerebrovascular accidents (CVA) or a CVA <6 months before treatment Subjects having received prior pancreatic surgery, radiation therapy, for pancreatic cancer of any histology Subjects with tumors extending to or invading the duodenum Subjects with recurrent/relapsed pancreatic cancer Progressive disease on pre-protocol enrollment studies for patients already on systemic therapy Subjects with pancreatitis Subjects in their reproductive age who are breast feeding or have a positive pregnancy test Any co-morbid condition such as but not limited to congestive heart failure, cardiac arrhythmia, or psychiatric illness of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician Concurrent active infection Prior malignancies other than cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer within the past 3 years Patient with known historical or active infection with HIV Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection with HBV deoxyribonucleic acid (DNA) > 500 IU/mL (or 2500 copies/mL) at screening Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to screening Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies Subjects with greater than grade 2 peripheral neuropathy History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirement of the study or to provide consent Inability or unwillingness to provide informed consent Currently enrolled in another investigational drug or device trial that clinically interferes with this study.

Sites / Locations

  • University of MarylandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VectRx Thermal Therapy

Arm Description

Device performance

Outcomes

Primary Outcome Measures

Performance of the VectRx device in its ability to increase temperature in the pancreas
Temperature change in patient internal and surface temperature probes measured in degree Celsius during each heat therapy (HT)
Safety of the VectRx treatment evaluated by incidence of Adverse events (AEs) such as first and second-degree burns, edema and abdominal pain, will be assessed [safety and tolerability].
AEs including serious adverse events (SAEs), including 1st degree and 2nd degree burns, edema, and abdominal pain will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5 November 2017) during each heat therapy (HT) and chemotherapy (CT) treatment.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
July 26, 2023
Sponsor
NeoTherma Oncology
Collaborators
University of Maryland, Baltimore, Databean
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1. Study Identification

Unique Protocol Identification Number
NCT05959395
Brief Title
Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors
Official Title
Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy Added to Chemotherapy Treatment of Pancreatic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoTherma Oncology
Collaborators
University of Maryland, Baltimore, Databean

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, tumors of the pancreas are treated with a device placed around the abdomen that creates an electromagnetic field that generates heat in the tumor. Heating the tumor improves blood flow and the delivery of chemotherapy to the tumor as has been shown in numerous studies for various cancers with potential clinical benefits. Subjects will receive the thermal treatment on the same day and prior to receiving standard of care chemotherapy for a total of 4 treatments. This study is an early feasibility study that aims to demonstrate the safety and the performance of the device.
Detailed Description
NeoTherma Oncology (NTO) is evaluating the initial safety and device functionality of VectRx, a medical device that produces a locoregional thermal effect through a Radiofrequency (RF)- generated Electromagnetic Field (EMF). VectRx therapy is intended for use as added to standard of care chemotherapy treatment of pancreatic ductal adenocarcinoma (PDAC). This treatment is intended to improve perfusion and re-oxygenate in the tumor microenvironment (TME) of deep solid tumors. This study will enroll up to 5 subjects who will receive treatment with the VectRx device in conjunction with standard of care Chemotherapy. Safety will be evaluated by the type and severity of AEs while functionality (ability to heat) will be assessed using precisely placed temperature probes. Together these results will provide an initial assessment of safety and functionality. Up to 5 adult subjects with pancreatic adenocarcinoma (primary and metastatic) recommended for chemotherapy based on multi-disciplinary tumor board evaluation including borderline resectable (BR) or unresectable (UR) Locally Advanced Pancreatic Cancer (LAPC), high risk resectable patients felt to benefit from chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VectRx Thermal Therapy
Arm Type
Experimental
Arm Description
Device performance
Intervention Type
Device
Intervention Name(s)
VectRx Thermal Therapy
Intervention Description
Subjects will receive VectRx thermal treatment added to 2 cycles of chemotherapy regimen. The VectRx device will be used under continuous investigator monitoring of internal tissue temperatures via real-time temperature probe data, as well as clinical signs and symptoms reflecting the objectives described above. Up to 5 study subjects will be treated. They will complete VectRx treatment during day 1 prior to 5-FU based (e.g., mFOLFIRINOX) or Gemcitabine based (e.g., Gemcitabine/Nab Paclitaxel) chemotherapy infusion. Thermal treatment will be carefully ramped-up to achieve staged goals of average tumor temperatures between 38°C and 43°C for total treatment times up to 30-70 minutes. The target temperature will be 41.5°C.
Primary Outcome Measure Information:
Title
Performance of the VectRx device in its ability to increase temperature in the pancreas
Description
Temperature change in patient internal and surface temperature probes measured in degree Celsius during each heat therapy (HT)
Time Frame
3 months
Title
Safety of the VectRx treatment evaluated by incidence of Adverse events (AEs) such as first and second-degree burns, edema and abdominal pain, will be assessed [safety and tolerability].
Description
AEs including serious adverse events (SAEs), including 1st degree and 2nd degree burns, edema, and abdominal pain will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5 November 2017) during each heat therapy (HT) and chemotherapy (CT) treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide signed and dated informed consent form Subjects who are > 18 years old Histologically or cytologically proven adenocarcinoma of the pancreas Subjects who enrolled prior to- or during initial course of planned chemotherapy. Subjects with other histology that would typically receive these regimens are included (i.e. adenosquamous) BR and UR Pancreatic Cancer based on modified NCCN guideline will be used as a guide for radiographic findings (94), or high risk resectable pancreatic cancer recommended by a multi-disciplinary team for chemotherapy based on NCCN recommendations (NCCN version 2.2021). Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT Eastern Cooperative Oncology Group (ECOG) performance of 0-1 (Appendix D) Estimated life expectancy > 9 months If female patient is of child-bearing potential, she must have a negative serum pregnancy test (βhCG) documented at screening Subjects who meet the following baseline organ function parameters: Absolute neutrophil count >/= 1,500cells/mm3 Platelets >100,000cells/mm3 Total Bilirubin ≤1.5X normal institutional limits OR < 2.0 ULN if stenting occurred AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2 Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection must meet the following criteria: HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at screening. Subjects with cured hepatitis C virus (HCV) infection at screening can be enrolled but should have HBV DNA levels checked periodically while on study to monitor for reactivation. Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab (-) HCV Ab (+) and HCV RNA (-) Exclusion Criteria: Subjects with any part of the body between the hips and shoulders >46 inch circumference, with an anterior posterior depth of ~10.5" in a supine position (fit may vary with body shape) Subjects unable to tolerate magnetic resonance imaging Subjects receiving treatment with other radiofrequency medical devices Subject has pacemaker, electrocardiograph, implanted defibrillator, infusion pumps, insulin pumps, cardiac monitoring electrodes and devices, deep brain stimulators, cochlear implants, radiofrequency identification devices attached to devices, or any implanted active electronic device or monitoring system, adhesive skin patches including conductive metal Metal biliary stents (plastic stents are allowed) Non-removable implanted designated MR unsafe and/or RF incompatible ferromagnetic metallic devices such as metal joint replacements Subjects who have ferromagnetic or electrically conductive, metal, or foreign objects in or on or attached to their body Severe pulmonary disease with a forced expiratory volume (FEV) <50% Unstable angina pectoris (under medication) with imminent threat of an infarction Myocardial infarction <6 months ago Cardiac decompensation or arrhythmia necessitating medication Systolic blood pressure >180 mmHg and/or <90 mmHg, while using medication Diastolic blood pressure >100 mmHg and/or <50 mmHg, while using medication Open skin wounds on the torso Severe cerebrovascular disease: multiple cerebrovascular accidents (CVA) or a CVA <6 months before treatment Subjects having received prior pancreatic surgery, radiation therapy, for pancreatic cancer of any histology Subjects with tumors extending to or invading the duodenum Subjects with recurrent/relapsed pancreatic cancer Progressive disease on pre-protocol enrollment studies for patients already on systemic therapy Subjects with pancreatitis Subjects in their reproductive age who are breast feeding or have a positive pregnancy test Any co-morbid condition such as but not limited to congestive heart failure, cardiac arrhythmia, or psychiatric illness of sufficient severity to limit full compliance with the protocol per assessment by the individual treating physician Concurrent active infection Prior malignancies other than cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer within the past 3 years Patient with known historical or active infection with HIV Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection with HBV deoxyribonucleic acid (DNA) > 500 IU/mL (or 2500 copies/mL) at screening Patient who has undergone recent major surgery, other than diagnostic surgical procedure within 4 weeks prior to screening Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies Subjects with greater than grade 2 peripheral neuropathy History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirement of the study or to provide consent Inability or unwillingness to provide informed consent Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Kitzmiller, MPH
Phone
(410) 369-5264
Email
kelly.kitzmiller@umm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Floriano, PhD
Organizational Affiliation
NeoTherma Oncology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jason Molitoris, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Kitzmiller, MPH
Phone
410-369-5264
Email
kelly.kitzmiller@umm.edu
First Name & Middle Initial & Last Name & Degree
Jason Molitoris, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.neothermaoncology.com
Description
Sponsor's website

Learn more about this trial

Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors

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