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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment VectRx Thermal Therapy for pancreatic cancer?

Research shows that using hyperthermia (heating the body) with chemotherapy and radiation can help improve survival and tumor response in pancreatic cancer patients. This suggests that VectRx Thermal Therapy, which involves hyperthermia, might also be effective. ^{1 2 3 4 5}

Is hyperthermia treatment generally safe for humans?

Hyperthermia treatment has been studied for safety in humans, showing some side effects like skin issues, infections, and discomfort, but no fatalities. In some studies, patient discomfort led to stopping the treatment early, but newer devices have improved tolerance. ^{2 6 7 8 9}

How does hyperthermia treatment differ from other treatments for pancreatic cancer?

Hyperthermia treatment, specifically modulated electro-hyperthermia (mEHT), is unique because it uses heat to enhance the effects of chemotherapy and radiotherapy, leading to increased survival and tumor response in pancreatic cancer patients. This approach also induces cancer cell death and improves blood flow to counteract the tumor's resistance to conventional treatments. ^{1 2 10 11 12}

Research Team

Pierre Floriano, PhD

Principal Investigator

NeoTherma Oncology

Jason Molitoris, MD

Principal Investigator

University of Maryland

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Regional hyperthermia combined with chemoradiotherapy in primary or recurrent locally advanced pancreatic cancer : an open-label comparative cohort trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Modulated electro-hyperthermia in stage III and IV pancreatic cancer: Results of an observational study on 158 patients. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The clinical benefit of hyperthermia in pancreatic cancer: a systematic review. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperthermia and radiation therapy for locally advanced or recurrent breast cancer. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic hyperthermia: The old, the new, and the upcoming. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I/II study, combination of radiotherapy and hyperthermia in patients with deep-seated malignant tumors: report of a pilot study by the Radiation Therapy Oncology Group. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Nanoparticle-based hyperthermia distinctly impacts production of ROS, expression of Ki-67, TOP2A, and TPX2, and induction of apoptosis in pancreatic cancer. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A phase I/II study to evaluate radiation therapy and hyperthermia for deep-seated tumours: a report of RTOG 89-08. [2019]

9. Greece pubmed.ncbi.nlm.nih.gov

Intraoperative radiation-therapy combined with hyperthermia for pancreatic-carcinoma. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Hyperthermia Reduces Irradiation-Induced Tumor Repopulation in an In Vivo Pancreatic Carcinoma Model. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Hyperthermia combined with chemotherapy vs chemotherapy in patients with advanced pancreatic cancer: A multicenter retrospective observational comparative study. [2023]