Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient. The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with solid tumors. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects. Since immunologically based treatment of various solid tumors is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens. The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes. This trial is explorative, prospective, open and non-randomized. Thirty patients diagnosed with solid tumors will be treated in this trial, which is estimated to be carried out during a time period of 18 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.
University Hospital Frankfurt
Frankfurt am Main, Germany
Treatment effect (Measurement of tumor burden by irRC criteria)
Measurement of tumor burden by irRC criteria.
Time frame: 18 months
Inflammatory response in tumor measured by quantification of inflammatory cell populations
Quantification of cellular infiltrate and activation markers by immunohistochemistry.
Time frame: 18 months
Inflammatory response in circulation measured by quantification of inflammatory cell populations
Quantification of cellular infiltrate and activation markers by flow cytometry.
Time frame: 18 months
Safety (adverse events)
Evaluation of adverse events.
Time frame: 18 months
Evaluation of pain (measured by VAS)
Evaluation of pain is performed using the visual analog scale (VAS).
Time frame: 18 months
Evaluation of Quality of Life (using a standardized questionnaire)
Evaluation of Quality of Life is evaluated using a standardized questionnaire (EORTC, general).
Time frame: 18 months
Usability of the device as evaluated by treatment logs
Evaluation of the laser system by analysis of treatment logs of the device.
Time frame: 18 months
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