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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 : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
ElmediX

Tracking Information
First Submitted Date  ICMJE June 24, 2020
First Posted Date  ICMJE July 13, 2020
Last Update Posted Date December 17, 2020
Estimated Study Start Date  ICMJE December 28, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Incidence of adverse device events (ADEs) in relation to the medical device [ Time Frame: 4 weeks after last treatment ]
  • Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters [ Time Frame: 4 weeks after last treatment ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • 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
  • 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
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Whole Body Hyperthermia for Advanced Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Pancreatic Cancer Metastatic
Intervention  ICMJE
  • Device: Whole body hyperthermia device
    Whole body hyperthermia to treat stage IV cancer patients
  • 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
Study Arms  ICMJE
  • 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)
    Intervention: Device: Whole body hyperthermia device
  • 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.
    Intervention: Device: Whole body hyperthermia device
  • 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).
    Intervention: Device: Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine
  • 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.
    Intervention: Device: Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oleg Rudenko, MD MSc +3215262981 oleg.rudenko@elmedix.com
Contact: Ivana Gorbaslieva, MSc +3215262981 ivana.gorbaslieva@elmedix.com
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04467593
Other Study ID Numbers  ICMJE MATTERS 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ElmediX
Study Sponsor  ICMJE ElmediX
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Peeters, MD PhD University Hospital, Antwerp
PRS Account ElmediX
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP