Safety Study of Whole Body Hyperthermia for Advanced Cancer

NCT04467593 | Completed DMC

• 1 other identifier: MATTERS 1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. The sponsor has developed a novel device to use hyperthermia for advanced cancer. This study is to prove the safety in human patients of this device \& therapy and get the first data on efficacy.

Conditions

Advanced Cancer; Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse device events (ADEs) in relation to the medical device

  4 weeks after last treatment

• Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters

  4 weeks after last treatment

• Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with SOC chemotherapy according to the NCCN guidelines. nab-paclitaxel or gemcitabine alone

  4 weeks after last treatment

Secondary Outcomes (3)

• evolution of CA19-9 (U/ml)

  4 weeks after last treatment

• evolution of CEA (ng/ml)

  4 weeks after last treatment

• based on the three primary outcome measures, guidance will be drafted for phase II treatment duration in combination with chemotherapy dosing.

  4 weeks after last treatment

Study Arms (5)

Cohort A1

EXPERIMENTAL

Three patients with advanced solid cancer will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15)

Device: Whole body hyperthermia

Cohort A2

EXPERIMENTAL

One patient with advanced solid cancer will receive 3 hyperthermia treatments of 4 hours per treatment. The next patient with advanced solid cancer will receive 3 hyperthermia treatments of 6 hours per treatment.

Device: Whole body hyperthermia

Cohort B

EXPERIMENTAL

Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Cohort C

EXPERIMENTAL

Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Cohort D

EXPERIMENTAL

Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Interventions

Whole body hyperthermia DEVICE

Whole body hyperthermia to treat stage IV cancer patients

Cohort A1; Cohort A2; Cohort B; Cohort C; Cohort D

Standard of Care (SOC) chemotherapy according to the NCCN guidelines. DRUG

Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy

Cohort B; Cohort C; Cohort D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18- and 75-years of age at time of signing the informed consent
• Patients with advanced solid cancer (for cohort A1, A2 only) or metastatic pancreatic adenocarcinoma confirmed by histology (for cohort B/C/D only)
• Patients previously treated or under treatment with standard of care treatment (cohort B/C/D only) or patients without treatment options
• WHO performance status ≤ 1(see appendix V)
• Maximum waist circumference ≤ 150 cm
• Weight ≤ 100 kg
• Height ≤ 1,90 m
• Adequate liver structure (confirmed by CT scan) allowing the placement of the liver sensor
• No (prostate) pathology that would interfere with the placement of the bladder catheter
• Adequate bone marrow function defined as
• white blood cell count ≥ 2000/µl
• neutrophils ≥ 1500 cells/μL
• platelets ≥ 100 x 109/L
• hemoglobin ≥ 10 g/dl documented within 1 week prior to first treatment
• Adequate coagulation defined as

You may not qualify if:

• Pregnant or breastfeeding women (based on HCG levels)
• Presence of brain metastasis (known or suspected)
• Other malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin)
• Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk, coronary stenting or myocardial infarction in the last year
• Clinically significant pulmonary disease which might interfere with mechanical ventilation
• History of autonomic dysfunction (due to the influence on skin blood flow)
• History of malignant hyperthermia or a positive diagnostic test (Caffeine-Halothane Contracture test) in case of family history of malignant hyperthermia.
• History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).
• Primary diabetes type I (due to vascular complications)
• Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, (chemotherapy used in cohort B/C/D))
• Active infections not controlled by medication
• Severe, non-healing wounds, ulcers or bone fractures
• Organ allografts requiring immunosuppressive therapy
• (History of) clinically significant (investigator decision) psychiatric disorder and/or psychosocial disorder that may interfere with adequate compliance to the protocol or signature of the informed consent
• Other clinically significant disease which could impair the patient's ability to participate in the study according to the investigator's opinion

Sponsors & Collaborators

• ElmediX: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marc Peeters, MD PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 13, 2020
• Study Start: July 28, 2021
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)