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Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma

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ClinicalTrials.gov Identifier: NCT02650492
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Clinical Laserthermia Systems AB

Brief 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.


Condition or disease Intervention/treatment Phase
Melanoma Malignant Melanoma Device: Immunostimulating Interstitial Laser Thermotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Study on Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma
Actual Study Start Date : October 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.




Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: 18 months ]
    Evaluation of adverse events.

  2. 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.

  3. Usability of the device as evaluated by user questionnaire [ Time Frame: 18 months ]
    Evaluation of the laser system by analysis of user questionnaire.


Secondary Outcome Measures :
  1. Treatment effect (Measurement of tumor burden by irRC criteria) [ Time Frame: 18 months ]
    Measurement of tumor burden by irRC criteria.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650492


Contacts
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Contact: Ingela Nylander, MSc +46 (0)72 177 29 81 ingela@clinicallaser.se

Locations
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Sweden
Karolinska University Hospital Solna Recruiting
Stockholm, Sweden, 17176
Contact: Johan Hansson, MD PhD         
Principal Investigator: Johan Hansson, MD PhD         
Sponsors and Collaborators
Clinical Laserthermia Systems AB
Investigators
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Principal Investigator: Johan Hansson, MD PhD Karolinska Institutet

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Responsible Party: Clinical Laserthermia Systems AB
ClinicalTrials.gov Identifier: NCT02650492     History of Changes
Other Study ID Numbers: CTP-2015-004
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Clinical Laserthermia Systems AB:
Hyperthermia, Induced
Laser Coagulation
Laser Therapy

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas