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Safety Study of Whole Body Hyperthermia for Advanced Cancer (MATTERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467593
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
ElmediX

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Pancreatic Cancer Metastatic Device: Whole body hyperthermia device Device: Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Mono-centric, First In-human (FIH), Safety and Preliminary Efficacy Study of (Neo)Adjuvant, Model-based, Whole-body Hyperthermia (WBHT) Treatment in Advanced Solid Cancer Patients or Stage IV (TxNxM1) Metastatic Pancreatic Adenocarcinoma Patients
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/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 device
Whole body hyperthermia to treat stage IV cancer patients

Experimental: Cohort A2
The highest whole-body hyperthermia duration with acceptable side effects from cohort A1 will be applied to three additional patients with advanced solid cancer, once a week and for 15 days in total.
Device: Whole body hyperthermia device
Whole body hyperthermia to treat stage IV cancer patients

Experimental: Cohort B1
Three pancreatic cancer patients will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15) using the device and in combination with the standard of care chemotherapy (FOLFIRINOX, FOLFOX, gemcitabine/nab-paclitaxel or gemcitabine alone).
Device: Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine
Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy

Experimental: Cohort B2
The highest whole-body hyperthermia duration with acceptable side effects from cohort B1 will be applied in combination with chemotherapy (FOLFIRINOX, FOLFOX, gemcitabine/nabpaclitaxel or gemcitabine alone) to three additional pancreatic cancer patients, once a week and for 15 days in total.
Device: Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine
Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy




Primary Outcome Measures :
  1. Incidence of adverse device events (ADEs) in relation to the medical device [ Time Frame: 4 weeks after last treatment ]
  2. Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters [ Time Frame: 4 weeks after last treatment ]
  3. Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with FOLFIRINOX, FOLFOX, gemcitabine/ nab-paclitaxel or gemcitabine alone [ Time Frame: 4 weeks after last treatment ]

Secondary Outcome Measures :
  1. evolution of CA19-9 (U/ml) [ Time Frame: 4 weeks after last treatment ]
    The evolution of this clinically significant biological parameter will be measured compared to baseline

  2. evolution of CEA (ng/ml) [ Time Frame: 4 weeks after last treatment ]
    The evolution of this clinically significant biological parameter will be measured compared to baseline

  3. based on the three primary outcome measures, guidance will be drafted for phase II treatment duration in combination with chemotherapy dosing. [ Time Frame: 4 weeks after last treatment ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 A only) or metastatic pancreatic adenocarcinoma confirmed by histology (for cohort B only)
  3. Patients previously treated (for cohort A and B) or under treatment with standard of care treatment (cohort B only)
  4. WHO performance status ≤ 1(see appendix V)
  5. BMI ≤ 32 kg/m2
  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. Quick-value ≥ 70% (± 1.15 x ULN)
    2. aPTT ≤ 2.5 x ULN, documented within 1 week prior to first treatment
    3. Fibrinogen ± 1.15 x ULN
    4. D-dimers ± 1.15 x ULN
    5. Protein-C ± 1.15 x ULN
    6. Factor VIII ± 1.15 x ULN
    7. Factor IX ± 1.15 x ULN
    8. Von Willebrand Factor ± 1.15 x 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 and B) or during WBHT treatment (for Cohort A)
  20. No transdermal patches
  21. No piercings (internally or externally)
  22. Life expectancy of at least 18 weeks
  23. Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
  24. 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))
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467593


Contacts
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Contact: Oleg Rudenko, MD MSc +3215262981 oleg.rudenko@elmedix.com
Contact: Ivana Gorbaslieva, MSc +3215262981 ivana.gorbaslieva@elmedix.com

Locations
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Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Marc Peeters, Professor    +3238213000    oncologie@uza.be   
Principal Investigator: Dirk Ysebaert, Professor         
Principal Investigator: Vera Saldien, MD         
Sponsors and Collaborators
ElmediX
Investigators
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Principal Investigator: Marc Peeters, MD PhD University Hospital, Antwerp
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Responsible Party: ElmediX
ClinicalTrials.gov Identifier: NCT04467593    
Other Study ID Numbers: MATTERS 1
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperthermia
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Gemcitabine
Paclitaxel
Folfirinox
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs