NCT02650492

Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

Exploratory Study on Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Clinical Laserthermia Systems AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma
• Malignant Melanoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-11-01
• Completion: 2019-05-01
• First posted: 2016-01-08
• Last updated: 2021-07-07

Locations

1 site across 1 country: Sweden