Heating pancreatic tumors to enhance chemotherapy effectiveness

Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy Added to Chemotherapy Treatment of Pancreatic Tumors

This study is testing if a special device that heats pancreatic tumors can help make chemotherapy work better for people with pancreatic cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NeoTherma Oncology (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05959395 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and functionality of the VectRx device, which generates heat through an electromagnetic field to improve blood flow and chemotherapy delivery to pancreatic tumors. Participants will receive thermal treatment on the same day as their standard chemotherapy for a total of four sessions. The study aims to assess the device's ability to safely heat tumors and enhance the effectiveness of chemotherapy in patients with pancreatic adenocarcinoma. Up to five adult subjects will be enrolled, and their safety will be monitored through adverse event reporting.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with histologically confirmed pancreatic adenocarcinoma who are recommended for chemotherapy.

Not a fit: Patients with non-adenocarcinoma pancreatic tumors or those not recommended for chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with pancreatic cancer by enhancing the effectiveness of chemotherapy.

How similar studies have performed: Previous studies have shown promising results using thermal therapies in conjunction with chemotherapy for various cancers, suggesting potential for success in this novel application.

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.

Where this trial is running

Baltimore, Maryland

• University of Maryland — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Jason Molitoris, MD — University of Maryland
• Study coordinator: Kelly Kitzmiller, MPH

Conditions Pancreatic Cancer