Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT02650492|
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : January 30, 2019
Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherpy (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 investigate the functionality and safety of the imILT treatment method in patients diagnosed with malignant melanoma. The inflammatory process, following on the treatment, will also be described in order to provide a more in depth knowledge of the treatment for this indication. The purpose is also to evaluate efficiency when it comes to local tumor destruction as well as understanding of the subsequent immunological effects. Since immunologically based treatment of malignant melanoma 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. Five malignant melanoma patients stage III - IV will be treated in this trial, which is estimated to be carried out during a time period of 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Malignant Melanoma||Device: Immunostimulating Interstitial Laser Thermotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Study on Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma|
|Actual Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||October 2020|
Immunostimulating Interstitial Laser Thermotherapy (imILT)
Device: Immunostimulating Interstitial Laser Thermotherapy
Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.
- Safety (adverse events) [ Time Frame: 18 months ]Evaluation of adverse events.
- Usability of the device as evaluated by treatment logs [ Time Frame: 18 months ]Evaluation of the laser system by analysis of treatment logs of the device.
- Usability of the device as evaluated by user questionnaire [ Time Frame: 18 months ]Evaluation of the laser system by analysis of user questionnaire.
- Treatment effect (Measurement of tumor burden by irRC criteria) [ Time Frame: 18 months ]Measurement of tumor burden by irRC criteria.
- Inflammatory response in tumor and circulation measured by quantification of inflammatory cell populations [ Time Frame: 18 months ]Quantification of cellular infiltrate and activation markers by immunohistochemistry and flow cytometry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650492
|Contact: Ingela Nylander, MSc||+46 (0)72 177 29 email@example.com|
|Karolinska University Hospital Solna||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Johan Hansson, MD PhD|
|Principal Investigator: Johan Hansson, MD PhD|
|Principal Investigator:||Johan Hansson, MD PhD||Karolinska Institutet|