Hyperthermia Treatment Added to Chemotherapy Standard of Care for Pancreatic Tumors

NCT05959395 | Unknown DMC FDA Device

• 1 other identifier: GCC 20122
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

  3 months

• 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.

  3 months

Study Arms (1)

VectRx Thermal Therapy

EXPERIMENTAL

Device performance

Device: VectRx Thermal Therapy

Interventions

VectRx Thermal Therapy DEVICE

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.

VectRx Thermal Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoTherma Oncology: lead
• University of Maryland, Baltimore: collaborator
• Databean: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Related Links

• Sponsor's website

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Pierre Floriano, PhD

  NeoTherma Oncology

  STUDY DIRECTOR

• Jason Molitoris, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Kitzmiller, MPH

CONTACT

(410) 369-5264; kelly.kitzmiller@umm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 25, 2023
• Study Start: August 15, 2023
• Primary Completion: February 28, 2024
• Study Completion: April 30, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)