Safety Study of Whole Body Hyperthermia for Advanced Cancer

Not Applicable

Recruiting

• Conditions: Advanced Cancer; Pancreatic Cancer Metastatic
• Interventions: Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

• Registration Number: NCT04467593
• Lead Sponsor: ElmediX

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 available

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2021-07-28
• Status Verified: 2023-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort D	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.
Cohort A1	Whole body hyperthermia	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)
Cohort B	Whole body hyperthermia	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.
Cohort B	Standard of Care (SOC) chemotherapy according to the NCCN guidelines.	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.
Cohort C	Whole body hyperthermia	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.
Cohort C	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.
Cohort D	Whole body hyperthermia	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.
Cohort A2	Whole body hyperthermia	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.

Primary Outcome Measures

Name	Time	Method
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	4 weeks after last treatment
Incidence of adverse device events (ADEs) in relation to the medical device	4 weeks after last treatment
Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters	4 weeks after last treatment

Secondary Outcome Measures

Name	Time	Method
evolution of CEA (ng/ml)	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.	4 weeks after last treatment
evolution of CA19-9 (U/ml)	4 weeks after last treatment	The evolution of this clinically significant biological parameter will be measured compared to baseline

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerpen, Belgium