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

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    14
  • sponsor
    ElmediX
Updated on 15 May 2022

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.

Details
Condition Advanced Cancer, Pancreatic Cancer Metastatic
Treatment Whole body hyperthermia device, Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine, Whole body hyperthermia, Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
Clinical Study IdentifierNCT04467593
SponsorElmediX
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
PT (%) ≥ 70%
aPTT ≤ ULN
Von Willebrand Factor Antigen ≥ LLN
Von Willebrand Factor Activity ≥ LLN
PFA COL/EPI CT ≤ 1.15 ULN
PFA COL/ADP CT ≤ 1.15 ULN
Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis
bilirubin ≤ 2 x ULN documented
Adequate liver function defined as
serum creatinine ≤ 1.6 mg/dL (male); ≤ 1.3 mg/dL (female)
albumin ≥ 30g/L
Adequate renal function defined as
calculated eGFR ≥ 60 mL/min (CKD-EPI equation) documented within 1 week prior to randomization
No blood donation 3 months prior to the WBHT treatment
No participation in other clinical trial 4 weeks prior to the WBHT treatment
No biological therapy 4 weeks prior to the WBHT treatment or during WBHT treatment
No surgery 4 weeks prior to the WBHT treatment
No chemotherapy 1 week prior to the WBHT treatment (for cohort A/B/C/D) or during WBHT treatment (for Cohort A1/A2)
No anti-platelet aggregation medication intake from 5 days prior to the first WBHT treatment until 5 days after the last treatment
No radiotherapy 3 weeks prior to the WBHT treatment or during WBHT treatment
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
No transdermal patches during participation in the study
No piercings (internally or externally)during WBHT treatment
Life expectancy of at least 18 weeks
Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit
Written informed consent must be given according to good clinical practice and national/local regulations

Exclusion Criteria

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
Participation in another clinical trial during this trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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