NCT02690428

Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers

To Evaluate the Safety & Palliative Treatment Effect on Patients With Solid Cancers by Immunostimulating Interstitial Laser Thermotherapy (imILT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (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 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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DEVICE	Immunostimulating Interstitial Laser Thermotherapy	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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-02-24
• Last updated: 2019-01-30

Locations

1 site across 1 country: Germany