Safety Study of Whole Body Hyperthermia for Advanced Cancer

Korábbi kezelés

• Organ allografts requiring immunosuppressive therapy

Más betegség

• 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
• (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

Egyéb

• Pregnant or breastfeeding women (based on HCG levels)
• Presence of brain metastasis (known or suspected)
• Severe, non-healing wounds, ulcers or bone fractures
• Participation in another clinical trial during this trial

• 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
• Adequate liver function defined as
  • Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis
  • bilirubin ≤ 2 x ULN documented
• Adequate renal function defined as
  • serum creatinine ≤ 1.6 mg/dL (male); ≤ 1.3 mg/dL (female);
  • albumin ≥ 30g/L
  • 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 radiotherapy 3 weeks prior to the WBHT treatment or during 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 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.