Hyperthermia Treatment for Pancreatic Cancer

Overseen By Kelly Kitzmiller, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeoTherma Oncology

Must not be taking: Anticoagulants, Antidepressants

Disqualifiers: Severe pulmonary disease, Unstable angina, Myocardial infarction, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called VectRx Thermal Therapy, which heats pancreatic tumors to enhance chemotherapy's effectiveness. The goal is to determine if this heat treatment can improve chemotherapy by increasing blood flow to the tumor. The trial seeks individuals diagnosed with pancreatic cancer who are about to begin chemotherapy. Participants will receive the heat treatment before chemotherapy sessions to assess the device's safety and effectiveness.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future cancer treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have certain implanted electronic devices or metal objects in your body, you may not be eligible to participate.

What prior data suggests that this device is safe for treating pancreatic cancer?

In a previous study, researchers found that combining heat treatment with chemotherapy can help treat pancreatic cancer. This heat treatment uses safe radio waves to warm the tumor. The goal is to improve blood flow and oxygen levels, enhancing the effectiveness of chemotherapy. Another study found that a specific power level achieved the largest treatment area without causing side effects. So far, the heat treatment has been well-tolerated by participants. Keep in mind, this early study demonstrates that the device is safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VectRx Thermal Therapy for pancreatic cancer because it leverages hyperthermia to target cancer cells. Unlike traditional treatments like chemotherapy and radiation, which attack both healthy and cancerous cells, hyperthermia selectively heats tumor tissues, potentially enhancing the effectiveness of other therapies and minimizing damage to surrounding healthy tissues. This approach not only aims to improve treatment outcomes but also seeks to reduce side effects, offering a promising new direction in the battle against this aggressive cancer.

What evidence suggests that this device is effective for pancreatic cancer?

Research has shown that heating tumors, known as hyperthermia, can enhance the effectiveness of chemotherapy for pancreatic cancer. Studies have found that this method increases blood flow and oxygen to the tumor, aiding chemotherapy drugs in working more effectively. Previous research demonstrated that adding hyperthermia improved cancer control, with 65% of patients experiencing stable disease or better, and it also increased one-year survival rates. In this trial, participants will receive VectRx Thermal Therapy, which safely uses radiofrequency energy to heat the tumor without harming the skin or organs. These findings suggest that hyperthermia could be a promising addition to standard cancer treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason Molitoris, MD

Principal Investigator

University of Maryland

Pierre Floriano, PhD

Principal Investigator

NeoTherma Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My organ functions meet the required health standards.

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

You are expected to live for at least 9 more months.

Exclusion Criteria

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

I currently have an active infection.

I had a heart attack less than 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VectRx thermal therapy in conjunction with standard of care chemotherapy for pancreatic tumors. The treatment involves 4 sessions where the device is used to generate heat in the tumor prior to chemotherapy.

4 sessions

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on adverse events and device performance.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• VectRx Thermal Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: VectRx Thermal Therapy Experimental Treatment 1 Intervention

Device performance

Who Is Running the Clinical Trial?

NeoTherma Oncology

Lead Sponsor

Trials

1

Recruited

5+

Databean

Industry Sponsor

Trials

6

Recruited

780+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a study of 127 patients with locally advanced or recurrent breast cancer, combined hyperthermia (HT) and radiation therapy (RT) resulted in over 50% of patients achieving local control of their disease, which is significant given the challenges of treating these cases with RT alone.

Higher doses of radiation and longer durations of hyperthermia (specifically, thermal equivalent doses of 42.5 °C for at least 200 minutes) were associated with improved overall survival and treatment response, highlighting the importance of these factors in the effectiveness of the combined treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperthermia and radiation therapy for locally advanced or recurrent breast cancer. Refaat, T., Sachdev, S., Sathiaseelan, V., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-pancreatic-neoplasms-6-2023-007a6

Hyperthermia Treatment for Pancreatic Cancer This trial uses a device to heat pancreatic tumors, improving blood flow and oxygen levels to make chemotherapy more effective.

2. umms.org umms.org/ummc/pros/physician-briefs/cancer/radiation-oncology/thermal-therapy-for-pdac

UMGCCC Researchers Become First in the World to Offer ... Past studies have shown that hyperthermia may increase the effectiveness of chemotherapy. This device uses nontoxic radiofrequency energy to heat the tumor and ...

3. biospace.com biospace.com/neotherma-oncology-reports-on-the-safety-and-effectiveness-of-rf-generated-heat-delivery-in-preclinical-animal-studies-with-the-vectron-ttx-thermal-de

NeoTherma Oncology Reports On The Safety And ... Key Findings and Conclusions: Safety demonstrated by the absence of injury to skin, internal organs or blood chemistries from repeated thermal ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4412860/

Review: The Role of Hyperthermia in Treating Pancreatic ... Thus cancer control (CR + PR + SD) was 65 % and 1 year survival 51 % (versus expected 25 %). Negative side effects due to adding hyperthermia have not been ...

5. careacross.com careacross.com/clinical-trials/trial/NCT05959395

Hyperthermia Treatment Added to Chemotherapy Standard ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9745020/

Thermal ablation in pancreatic cancer: A scoping review ... Median overall survival was 7.4 months. It was determined that a power of 4 W and 1,000 J achieved the largest ablation volume without adverse ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00178763?draw=2&rank=1

Hyperthermia With Chemotherapy for Locally Advanced or ... Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells.