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.
You may not be if
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
Clareo Health | Safety Study of Whole Body Hyperthermia for Advanced Cancer
