Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers

Not Applicable

Terminated

• Conditions: Neoplasms

• Registration Number: NCT02690428
• Lead Sponsor: Clinical Laserthermia Systems AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Are male or female > 18 years of age
• Have histologically confirmed, locally uncontrolled, solid cancer, with or without metastases, that cannot be treated surgically due to unresectability or inoperability
• Have one or more tumours assessable by MRI/CT or ultrasound and situated in such a way that at least a part of the tumour can be treated with IMILT without damage to surrounding vital structures or the skin
• Are candidates for ablative intervention also outside this study
• Have given informed verbal and written consent to participation in the trial
• Have an ECOG performance status < 2 (Karnofsky > 60%)
• Have stable haematologic, renal and hepatic functions

Exclusion Criteria

• Are HIV positive
• Have an active autoimmune disease
• Are on systemic corticosteroid medication (local treatment with aerosol's and ointment is allowed)
• Have known bleeding disorders or are treated with anticoagulant medication
• Are pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment effect (Measurement of tumor burden by irRC criteria)	18 months	Measurement of tumor burden by irRC criteria.

Secondary Outcome Measures

Name	Time	Method
Inflammatory response in tumor measured by quantification of inflammatory cell populations	18 months	Quantification of cellular infiltrate and activation markers by immunohistochemistry.
Inflammatory response in circulation measured by quantification of inflammatory cell populations	18 months	Quantification of cellular infiltrate and activation markers by flow cytometry.
Safety (adverse events)	18 months	Evaluation of adverse events.
Evaluation of pain (measured by VAS)	18 months	Evaluation of pain is performed using the visual analog scale (VAS).
Evaluation of Quality of Life (using a standardized questionnaire)	18 months	Evaluation of Quality of Life is evaluated using a standardized questionnaire (EORTC, general).
Usability of the device as evaluated by treatment logs	18 months	Evaluation of the laser system by analysis of treatment logs of the device.

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt am Main, Germany