MelanomaNCT02650492
Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Melanoma and Malignant Melanoma, run by Clinical Laserthermia Systems AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Malignant Melanoma
- What is being tested?
- Immunostimulating Interstitial Laser Thermotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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%)
Who cannot join
- known HIV infection
- autoimmune disease which is judged to reduce an anti-tumour immune response
- systemic corticosteroid medication
- bleeding diathesis
- pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Melanoma, Malignant Melanoma
- Being tested
- Immunostimulating Interstitial Laser Thermotherapy
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Medical subject headings
- Melanoma, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunostimulating Interstitial Laser ThermotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| imILT | Experimental | Immunostimulating Interstitial Laser Thermotherapy (imILT) Receives: Device: Immunostimulating Interstitial Laser Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Evaluation of adverse events.
Measured: 18 months
Usability of the device as evaluated by treatment logs
Evaluation of the laser system by analysis of treatment logs of the device.
Measured: 18 months
Usability of the device as evaluated by user questionnaire
Evaluation of the laser system by analysis of user questionnaire.
Measured: 18 months
Secondary outcomes (2)
Treatment effect (Measurement of tumor burden by irRC criteria)
Measurement of tumor burden by irRC criteria.
Measured: 18 months
Inflammatory response in tumor and circulation measured by quantification of inflammatory cell populations
Quantification of cellular infiltrate and activation markers by immunohistochemistry and flow cytometry.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startOct 2015
- Primary completion1 Nov 2016
- Study completion1 May 2019
Why it stopped: Study was stopped in agreement with investigator due to slow patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Laserthermia Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Hansson, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650492
- Sponsor's protocol ID
- CTP-2015-004
- Status last verified
- Jul 2021
- First submitted
- 27 Nov 2015
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma
- ClinicalTrials.gov ID
- NCT02650492
- Acronym / sponsor ID
- CTP-2015-004
- Conditions
- Melanoma, Malignant Melanoma
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped in agreement with investigator due to slow patient recruitment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Clinical Laserthermia Systems ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imILT | Experimental | Device: Immunostimulating Interstitial Laser ThermotherapyImmunostimulating Interstitial Laser Thermotherapy (imILT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >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
Key exclusion criteria (5 listed)
- known HIV infection
- autoimmune disease which is judged to reduce an anti-tumour immune response
- systemic corticosteroid medication
- bleeding diathesis
- pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunostimulating Interstitial Laser ThermotherapyImmunostimulating 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. | Device | imILT |
Primary outcome
Safety (adverse events)
Time frame: 18 months
Evaluation of adverse events.
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.
Usability of the device as evaluated by user questionnaire
Time frame: 18 months
Evaluation of the laser system by analysis of user questionnaire.
2 secondary outcomes
Treatment effect (Measurement of tumor burden by irRC criteria)
Time frame: 18 months
Inflammatory response in tumor and circulation measured by quantification of inflammatory cell populations
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Study was stopped in agreement with investigator due to slow patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Hansson, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Melanoma and Malignant Melanoma, run by Clinical Laserthermia Systems AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped in agreement with investigator due to slow patient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (adverse events) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.