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Potential of Moderate Whole Body Hyperthermia to Enhance Response

RECRUITINGPhase 2Sponsored by Charite University, Berlin, Germany
Actively Recruiting
PhasePhase 2
SponsorCharite University, Berlin, Germany
Started2023-02-01
Est. completion2026-12-01
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted

Summary

Using moderate whole-body hyperthermia (mWBH) in tumor patients to see the influence on circulating tumor cells, tumor response, quality of life, fatigue, psyche, immune response and tumor microenvironment

Eligibility

Age: 18 Years – 100 YearsHealthy volunteers accepted
Inclusion Criteria:

* The general condition of the patients must be sufficient for multimodal treatment (corresponding to WHO status 0-2)
* Tumordisease in a palliative setting of the following 6 groups:

  1. Malignant melanoma, treatment-naive stage IV with multiple metastases and missing BRAF-V600 mutation. With indication for initiation of immunotherapy using PD-1 and CTLA-4 antibody therapy.
  2. Patients with metastatic or inoperable pancreatic cancer, who are planning first-line chemotherapy with FOLFIRINOX is.
  3. Patients with an indication for palliative radiation therapy extracranial, tumor manifestation with a prescribed radiation dose of 30 to 36 Gy due to hormone receptor-positive carcinoma of the breast, patients must have at least one additional (marker) lesion not treated with radiation.
  4. Patients with metastatic high-grade sarcoma for whom metastasis-directed ablative therapy methods are not possible and palliative first-line therapy with doxorubicin.
  5. Patients with metastatic or loco-regionally recurrent HPV-associated squamous cell carcinoma (of the head and neck region, cervix, anus or vulva) for whom local therapies are not possible and for whom palliative first-line therapy containing platinum is planned.
  6. Patients with metastatic, castration-resistant prostate cancer, with progressive disease after exceeding the recommended therapy options for which a therapy attempt with lutetium-177-PSMA was indicated.

Exclusion Criteria:

* Presence of contraindications to simultaneous chemotherapy or whole-body hyperthermia
* Serious or active comorbidities that could interfere with treatment or understanding of the nature and content of the study, for example:

  * Chronic inflammatory bowel disease
  * Acute infections
  * Serious cardiovascular or pulmonary comorbidities
  * Mental illnesses, showing the proper Study participation or recording the nature of the study to make impossible
  * Presence of cerebral metastasis
  * Diabetes mellitus with risk of end-organ damage

Conditions2

CancerOncology

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