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)

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 Overview

• Status: Terminated
• Conditions: Neoplasms
• Intervention / Treatment: Device: Immunostimulating Interstitial Laser Thermotherapy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • University Hospital Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: imILT; Immunostimulating Interstitial Laser Thermotherapy (imILT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment effect (Measurement of tumor burden by irRC criteria)	Measurement of tumor burden by irRC criteria.	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinical Laserthermia Systems AB

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Laser Therapy; Laser Coagulation; Hyperthermia, Induced
• Other Study ID Numbers: CTP-2014-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO