Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

July 2, 2021 updated by: Clinical Laserthermia Systems AB

Exploratory Study on Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • >18 years of age
  • histologically confirmed malignant melanoma
  • advanced melanoma disease (Stage III inoperable or Stage IV) that has progressed on standard first line treatment such as kinase inhibitor(s) and/or immunoregulatory monoclonal antibodies. Previously untreated patients with a dominant tumour lesion deemed suitable for local and highly tumour-destructive ablation may also be included
  • time interval between previous systemic treatment and imILT of at least one month
  • at least one lesion located in such a way (typically subcutaneously) that it can be treated without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue
  • verbal and written informed consent to participate
  • adequate haematologic, renal and hepatic functions
  • have an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)

Exclusion Criteria:

  • known HIV infection
  • autoimmune disease which is judged to reduce an anti-tumour immune response
  • systemic corticosteroid medication
  • bleeding diathesis
  • pregnancy or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: imILT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (adverse events)
Time Frame: 18 months
Evaluation of adverse events.
18 months
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.
18 months
Usability of the device as evaluated by user questionnaire
Time Frame: 18 months
Evaluation of the laser system by analysis of user questionnaire.
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Laserthermia Systems AB

Investigators

  • Principal Investigator: Johan Hansson, MD PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

January 7, 2016

First Posted (ESTIMATE)

January 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-2015-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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