What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as chemotherapy with drugs like gemcitabine and pemetrexed, can cause side effects including neutropenia, anemia, febrile neutropenia, fatigue, constipation, vomiting, and dehydration. Hyperthermia, used to enhance chemotherapy delivery, may cause local side effects like skin burns, pain, and discomfort at the treatment site. Combining these treatments aims to improve efficacy but may also increase the severity of side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, with a focus on combination chemotherapy regimens. Notably, gemcitabine combined with nab-paclitaxel has shown significant efficacy, with improved response rates and survival outcomes compared to gemcitabine alone. This combination therapy was validated in the MPACT trial, which demonstrated a higher objective response rate and longer median overall survival. These treatments aim to enhance the delivery and effectiveness of chemotherapy, similar to the goals of the hyperthermia treatment being studied, which uses an electromagnetic field to improve blood flow and chemotherapy delivery to the tumor.

What other types of research exist?

Promising novel alternatives to the Electromagnetic Field Device for pancreatic cancer treatment include: 1) Magnetic Nanoparticle Hyperthermia (mNPH), which uses ferromagnetic nanoparticles to generate localized heat and enhance treatment efficacy. 2) Microwave Hyperthermia, which can be delivered using invasive needle microwave antennas to produce local hyperthermia in deep-seated tumors. 3) Combination therapies involving hyperthermia and advanced drug delivery systems, such as nanoparticle-enhanced microwave hyperthermia, which shows potential for improving the rate and extent of therapeutic heating.

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Hyperthermia Treatment for Pancreatic Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer include chemotherapy and hyperthermia. Chemotherapy uses drugs to target and kill rapidly dividing cancer cells, but its effectiveness can be limited by poor blood flow to the tumor. Hyperthermia, which involves heating the tumor, can enhance chemotherapy by improving blood flow and making cancer cells more susceptible to the drugs. This combination is crucial for pancreatic cancer patients because the dense tissue and poor vascularization of pancreatic tumors often impede effective drug delivery.

N/A

Recruiting

Led By Jason Molitoris, MD

Research Sponsored by NeoTherma Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2

Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab (-) HCV Ab (+) and HCV RNA (-)

Must not have

Concurrent active infection

Myocardial infarction <6 months ago

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a device to heat pancreatic tumors, improving blood flow and oxygen levels to make chemotherapy more effective. It targets adults with pancreatic cancer who are recommended for chemotherapy. The study aims to test the safety and functionality of this heating device.

Who is the study for?

Adults over 18 with confirmed pancreatic adenocarcinoma, including high-risk resectable or borderline cases based on NCCN guidelines. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and have proper organ function. Pregnant women are excluded, as well as those with certain heart conditions, blood pressure issues, metal implants incompatible with the device, recent major surgery or other investigational trials interference.

What is being tested?

The trial is testing VectRx Thermal Therapy combined with standard chemotherapy for pancreatic tumors. The therapy involves a device that heats the tumor to improve chemotherapy delivery. Participants will undergo this treatment four times before their scheduled chemo sessions in an early-stage study assessing safety and performance.

What are the potential side effects?

Potential side effects may include discomfort from heat application, skin irritation at the treatment site, changes in blood pressure during treatment due to heat exposure, and typical chemotherapy-related side effects such as nausea, fatigue, hair loss and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal based on creatinine levels or clearance.

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I don't have active hepatitis B or C.

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I am fully active or can carry out light work.

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I am older than 18 years.

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My cancer is a type of pancreatic cancer confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active infection.

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I had a heart attack less than 6 months ago.

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I have pancreatitis.

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I need medication for heart failure or irregular heartbeat.

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I have severe nerve damage in my hands or feet.

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My blood pressure is either above 100 or below 50 mmHg despite medication.

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My lung function is severely reduced.

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I have hepatitis B with a viral load over 500 IU/mL.

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My blood pressure is either above 180 or below 90, even with medication.

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My cancer has worsened despite current treatment.

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My pancreatic cancer has come back after treatment.

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I cannot undergo MRI scans.

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I have had surgery or radiation for pancreatic cancer.

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I have had multiple strokes or a stroke less than 6 months ago.

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My cancer has spread to or is affecting my duodenum.

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I have HIV.

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I have severe chest pain due to heart issues, treated with medication.

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I have open skin wounds on my torso.

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I have a history of lung conditions like interstitial lung disease or sarcoidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance of the VectRx device in its ability to increase temperature in the pancreas

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].

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VectRx Thermal TherapyExperimental Treatment1 Intervention

Device performance

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy and hyperthermia. Chemotherapy uses drugs to target and kill rapidly dividing cancer cells, but its effectiveness can be limited by poor blood flow to the tumor. Hyperthermia, which involves heating the tumor, can enhance chemotherapy by improving blood flow and making cancer cells more susceptible to the drugs. This combination is crucial for pancreatic cancer patients because the dense tissue and poor vascularization of pancreatic tumors often impede effective drug delivery.