Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Pancreatic Cancer

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.

Whole body hyperthermia to treat stage IV cancer patients

Whole body hyperthermia

Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy

Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

Oleg Rudenko, MD MSc

Marc Peeters, Professor

Dirk Ysebaert, Professor

Vera Saldien, Professor

Marc Peeters, MD PhD

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.

Safety Study of Whole Body Hyperthermia for Advanced Cancer

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

The evolution of this clinically significant biological parameter will be measured compared to baseline

ElmediX

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days

ThermalCore Hyperthermia System

Jan Winetz, MD

To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.

This study is a prospective, single-arm phase I trial of 20 ovarian cancer patients to be treated with PISH for 6 cycles, delivered every 28 days. This mimics chemotherapy treatments, in concordance with the fractional cell kill hypothesis of cytotoxic agents.

As this study is for safety, only, metastatic peritoneal or ovarian cancer, of any histology (epithelial, sex-cord stromal, germ cell, or sarcoma) that has progressed after 2 cycles of chemotherapy, and is considered incurable, will be included. All patients must meet performance status and organ function entry criteria. Patients must have first undergone standard first line primary surgery and chemotherapy, and have then gone on to fail second line chemotherapy treatment, (with or without secondary cytoreductive surgeries). Patients must be candidates for, and expecting treatment by, the usual third line chemotherapy agent palliation traditionally offered by medical oncology. Patients may have received treatment beyond third-line therapy, as long as they meet entry requirements for this study.

A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer

Determine the frequency and severity of unexpected serious adverse events

Patients continue to meet the entry criteria for organ toxicity defined in the trial by the time prior to next scheduled treatment at 28 days.

Time To Progression (TTP, defined as the interval from treatment initiation to disease progression) for the cohort. Measurement of Time To Progression (TTP) for the cohort will be conducted using PET CT, CA-125, and physical examination. Progression is defined as radiologic progression RECIST criteria, CA-125 doubling per Gynecologic Intergroup Definition of progression of disease, or any evidence of palpable lesion growth on physical examination.

ThermalCore Inc

Recurrence

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Hypoxia

Disease Attributes

All Drugs and Chemicals

Fluoxymesterone

Additional application of weekly moderate whole-body hyperthermia concurrent to re-irradiation plus chemotherapy

four to six applications of whole Body hyperthermia concomitant to radiochemotherapy. Additional measurement of Perfusion and hypoxia by 18F-FMISO hypoxia PET and magnetic resonance Imaging

Moderate whole body hyperthermia using water-filtered IR-A-radiation

Sebastian Zschaeck, MD

The aim of the study is to determine the feasibility and efficacy of moderate weekly whole Body hyperthermia Treatment during radiochemotherapy for pre-irradiated locally or regionally recurrent head and neck squamous cell carcinomas.

The Primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia.

Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia, measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor hypoxia, measured by hypoxia specific Positron emission tomography.

Previously irradiated patients with loco/ loco-regional recurrent head and neck squamous cell carcinomas usually undergo re-irradiation. However prognosis of these patients is unfavourable, especially for non-human papilloma virus associated cancers. Moderate whole body hyperthermia will be performed by water-filtered IR-A-radiation using a Heckel-HT3000 device.

Preclinical data have indicated that moderate whole body hyperthermia decreases intratumoral interstitial fluid pressure and leads to increased perfusion of the tumor. The study investigates if this holds also true in patients and leads to a marked decrease of tumor hypoxia, measured by 18F-Fluoromisonidazole PET.

The Primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia.

Secondary endpoints include an increase of Tumor Perfusion by the use of hyperthermia, measured by magnetic resonance Imaging during week two of Treatment and reduction of Tumor hypoxia, measured by hypoxia specific Positron emission tomography.

Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment

Gemäßigte Ganzkörperhyperthermie Bei Patienten Mit Rezidivierten Plattenepithelkarzinomen Der Kopf-Hals Region Nach Hochdosierter Vorbestrahlung: Pilotstudie Zur Beeinflussung Des Tumormikromilieus.

pseudonymized data may be shared upon reasonable request if accepted by all participating ethical commissions

feasibility is defined as at least 4 cycles of whole body hyperthermia in 80% of patients

defined as at least 80% reduction of the tumor to background ratio measured at the end of the second week of treatment compared to pre-treatment

measured before treatment and at the end of week 2

measured by questionnaires according to EORTC (H\&N35) and Transformation of absolute values to percentual values.

measured by questionnaires according to EORTC (C30) and Transformation of absolute values to percentual values.

From start of re-irradiation. Analysis will be performed by cox regression and log-rank analyses.

Response of the irradiated tumor 3 months after end of treatment according to recist criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Whole Body Hyperthermia for Advanced Cancer	NCT04467593	Advanced Cancer Pancreatic Canc...	Whole body hype... Standard of Car...	18 Years - 75 Years	ElmediX
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer	NCT02093871	Ovarian Cancer	ThermalCore Hyp...	18 Years - 69 Years	ThermalCore Inc
Moderate Whole Body Hyperthermia for Patients Undergoing Re-irradiation for Head and Neck Cancer -Influence on the Tumor Microenvironment	NCT03547388	Head and Neck N... Recurrence Tumo...	Moderate whole ...	18 Years - 75 Years	Charite University, Berlin, Germany
Safety Study of Whole Body Hyperthermia for Advanced Cancer	NCT04467593	Advanced Cancer Pancreatic Canc...	Whole body hype... Standard of Car...	18 Years - 75 Years	ElmediX

Spots Global Cancer Trial Database for whole body hyperthermia