Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors

NeoTherma Oncology

Status

Enrolling

Conditions

Pancreatic Cancer

Treatments

Device: VectRx Thermal Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05959395

GCC 20122

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.