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

Primary Purpose

Advanced Cancer, Pancreatic Cancer Metastatic

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Whole body hyperthermia
Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
Sponsored by
ElmediX
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 A1, A2 only) or metastatic pancreatic adenocarcinoma confirmed by histology (for cohort B/C/D only)
  3. Patients previously treated or under treatment with standard of care treatment (cohort B/C/D only) or patients without treatment options
  4. WHO performance status ≤ 1(see appendix V)
  5. Maximum waist circumference ≤ 150 cm
  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. PT (%) ≥ 70%
    2. aPTT ≤ ULN
    3. Von Willebrand Factor Antigen ≥ LLN
    4. Von Willebrand Factor Activity ≥ LLN
    5. PFA COL/EPI CT ≤ 1.15 ULN
    6. PFA COL/ADP CT ≤ 1.15 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/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.

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/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

Sites / Locations

  • University Hospital AntwerpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A1

Cohort A2

Cohort B

Cohort C

Cohort D

Arm Description

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)

One patient with advanced solid cancer will receive 3 hyperthermia treatments of 4 hours per treatment. The next patient with advanced solid cancer will receive 3 hyperthermia treatments of 6 hours per treatment.

Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Outcomes

Primary Outcome Measures

Incidence of adverse device events (ADEs) in relation to the medical device
Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters
Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with SOC chemotherapy according to the NCCN guidelines. nab-paclitaxel or gemcitabine alone

Secondary Outcome Measures

evolution of CA19-9 (U/ml)
The evolution of this clinically significant biological parameter will be measured compared to baseline
evolution of CEA (ng/ml)
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.

Full Information

First Posted
June 24, 2020
Last Updated
February 15, 2023
Sponsor
ElmediX
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1. Study Identification

Unique Protocol Identification Number
NCT04467593
Brief Title
Safety Study of Whole Body Hyperthermia for Advanced Cancer
Acronym
MATTERS
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ElmediX

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Pancreatic Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A1
Arm Type
Experimental
Arm Description
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)
Arm Title
Cohort A2
Arm Type
Experimental
Arm Description
One patient with advanced solid cancer will receive 3 hyperthermia treatments of 4 hours per treatment. The next patient with advanced solid cancer will receive 3 hyperthermia treatments of 6 hours per treatment.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
Arm Title
Cohort D
Arm Type
Experimental
Arm Description
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
Intervention Type
Device
Intervention Name(s)
Whole body hyperthermia
Intervention Description
Whole body hyperthermia to treat stage IV cancer patients
Intervention Type
Drug
Intervention Name(s)
Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
Intervention Description
Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
Primary Outcome Measure Information:
Title
Incidence of adverse device events (ADEs) in relation to the medical device
Time Frame
4 weeks after last treatment
Title
Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters
Time Frame
4 weeks after last treatment
Title
Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with SOC chemotherapy according to the NCCN guidelines. nab-paclitaxel or gemcitabine alone
Time Frame
4 weeks after last treatment
Secondary Outcome Measure Information:
Title
evolution of CA19-9 (U/ml)
Description
The evolution of this clinically significant biological parameter will be measured compared to baseline
Time Frame
4 weeks after last treatment
Title
evolution of CEA (ng/ml)
Description
The evolution of this clinically significant biological parameter will be measured compared to baseline
Time Frame
4 weeks after last treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oleg Rudenko, MD MSc
Phone
+3215262981
Email
oleg.rudenko@elmedix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Peeters, MD PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Peeters, Professor
Phone
+3238213000
Email
oncologie@uza.be
First Name & Middle Initial & Last Name & Degree
Dirk Ysebaert, Professor
First Name & Middle Initial & Last Name & Degree
Vera Saldien, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety Study of Whole Body Hyperthermia for Advanced Cancer

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