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Clinical Trial Record

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Safety Study of Whole Body Hyperthermia for Advanced Cancer

2021-07-28

2024-12-25

2024-12-25

16

Study Overview

Safety Study of Whole Body Hyperthermia for Advanced Cancer

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.

N/A

  • Advanced Cancer
  • Pancreatic Cancer Metastatic
  • DEVICE: Whole body hyperthermia
  • DRUG: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
  • MATTERS 1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-06-24  

N/A  

2025-08-04  

2020-07-08  

N/A  

2025-08-05  

2020-07-13  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Cohort A1

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

  • Whole body hyperthermia to treat stage IV cancer patients
EXPERIMENTAL: Cohort A2

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

  • Whole body hyperthermia to treat stage IV cancer patients
EXPERIMENTAL: Cohort B

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

  • Whole body hyperthermia to treat stage IV cancer patients

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

  • Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
EXPERIMENTAL: Cohort C

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

  • Whole body hyperthermia to treat stage IV cancer patients

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

  • Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
EXPERIMENTAL: Cohort D

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

  • Whole body hyperthermia to treat stage IV cancer patients

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

  • Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of adverse device events (ADEs) in relation to the medical device4 weeks after last treatment
Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters4 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 alone4 weeks after last treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
evolution of CA19-9 (U/ml)The evolution of this clinically significant biological parameter will be measured compared to baseline4 weeks after last treatment
evolution of CEA (ng/ml)The evolution of this clinically significant biological parameter will be measured compared to baseline4 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion criteria:
    1. Patients between 18- and 75-years of age at time of signing the informed consent 2. Patients with advanced solid cancer (for cohort A1, A2 only) or metastatic pancreatic adenocarcinoma confirmed by histology (for cohort B/C/D only) 3. Patients previously treated or under treatment with standard of care treatment (cohort B/C/D only) or patients without treatment options 4. WHO performance status ≤ 1(see appendix V) 5. Maximum waist circumference ≤ 150 cm 6. Weight ≤ 100 kg 7. Height ≤ 1,90 m 8. Adequate liver structure (confirmed by CT scan) allowing the placement of the liver sensor 9. No (prostate) pathology that would interfere with the placement of the bladder catheter 10. Adequate bone marrow function defined as
    1. white blood cell count ≥ 2000/µl 2. neutrophils ≥ 1500 cells/μL 3. platelets ≥ 100 x 109/L 4. hemoglobin ≥ 10 g/dl documented within 1 week prior to first treatment 11. Adequate coagulation defined as
    1. PT (%) ≥ 70% 2. aPTT ≤ ULN 3. Von Willebrand Factor Antigen ≥ LLN 4. Von Willebrand Factor Activity ≥ LLN 5. PFA COL/EPI CT ≤ 1.15 ULN 6. PFA COL/ADP CT ≤ 1.15 ULN 12. Adequate liver function defined as
    1. Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis 2. bilirubin ≤ 2 x ULN documented 13. Adequate renal function defined as
    1. serum creatinine ≤ 1.6 mg/dL (male); ≤ 1.3 mg/dL (female); 2. albumin ≥ 30g/L 3. calculated eGFR ≥ 60 mL/min (CKD-EPI equation) documented within 1 week prior to randomization 14. No blood donation 3 months prior to the WBHT treatment 15. No participation in other clinical trial 4 weeks prior to the WBHT treatment 16. No biological therapy 4 weeks prior to the WBHT treatment or during WBHT treatment 17. No surgery 4 weeks prior to the WBHT treatment 18. No radiotherapy 3 weeks prior to the WBHT treatment or during WBHT treatment 19. No chemotherapy 1 week prior to the WBHT treatment (for cohort A/B/C/D) or during WBHT treatment (for Cohort A1/A2) 20. No anti-platelet aggregation medication intake from 5 days prior to the first WBHT treatment until 5 days after the last treatment 21. No anticoagulant medication intake between screening and last follow-up visit. However, if deemed necessary by the investigator, the patient may receive prophylactic Low Molecular Weight Heparin on the day prior to the first WBHT treatment until 10 days after the last WBHT treatment 22. No transdermal patches during participation in the study 23. No piercings (internally or externally)during WBHT treatment 24. Life expectancy of at least 18 weeks 25. Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit. 26. Written informed consent must be given according to good clinical practice and national/local regulations.
    Exclusion criteria:
    1. Pregnant or breastfeeding women (based on HCG levels) 2. Presence of brain metastasis (known or suspected) 3. 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) 4. Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk, coronary stenting or myocardial infarction in the last year 5. Clinically significant pulmonary disease which might interfere with mechanical ventilation 6. History of autonomic dysfunction (due to the influence on skin blood flow) 7. History of malignant hyperthermia or a positive diagnostic test (Caffeine-Halothane Contracture test) in case of family history of malignant hyperthermia. 8. History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism). 9. Primary diabetes type I (due to vascular complications) 10. Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, (chemotherapy used in cohort B/C/D)) 11. Active infections not controlled by medication 12. Severe, non-healing wounds, ulcers or bone fractures 13. Organ allografts requiring immunosuppressive therapy 14. (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 15. Other clinically significant disease which could impair the patient's ability to participate in the study according to the investigator's opinion 16. Participation in another clinical trial during this trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Marc Peeters, MD PhD, University Hospital, Antwerp

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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