NeoplasmsNCT02690428
Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Neoplasms, run by Clinical Laserthermia Systems AB at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- 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
- 3 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Apr 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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. 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.
- Conditions
- Neoplasms
- Being tested
- Immunostimulating Interstitial Laser Thermotherapy
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Medical subject headings
- Neoplasms, 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 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.
| 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.
Treatment effect (Measurement of tumor burden by irRC criteria)
Measurement of tumor burden by irRC criteria.
Measured: 18 months
Secondary outcomes (6)
Inflammatory response in tumor measured by quantification of inflammatory cell populations
Quantification of cellular infiltrate and activation markers by immunohistochemistry.
Measured: 18 months
Inflammatory response in circulation measured by quantification of inflammatory cell populations
Quantification of cellular infiltrate and activation markers by flow cytometry.
Measured: 18 months
Safety (adverse events)
Evaluation of adverse events.
Measured: 18 months
Evaluation of pain (measured by VAS)
Evaluation of pain is performed using the visual analog scale (VAS).
Measured: 18 months
Evaluation of Quality of Life (using a standardized questionnaire)
Evaluation of Quality of Life is evaluated using a standardized questionnaire (EORTC, general).
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Patient recruitment slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Laserthermia Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690428
- Sponsor's protocol ID
- CTP-2014-003
- Status last verified
- Jan 2019
- First submitted
- 15 Feb 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety & Palliative Treatment Effect on Patients With Solid Cancers by Immunostimulating Interstitial Laser Thermotherapy (imILT)
- ClinicalTrials.gov ID
- NCT02690428
- Acronym / sponsor ID
- CTP-2014-003
- Conditions
- Neoplasms
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment slow
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Clinical Laserthermia Systems ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 24 Feb 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 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 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 (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 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. | Device | imILT |
Primary outcome
Treatment effect (Measurement of tumor burden by irRC criteria)
Time frame: 18 months
Measurement of tumor burden by irRC criteria.
6 secondary outcomes
Inflammatory response in tumor measured by quantification of inflammatory cell populations
Time frame: 18 months
Inflammatory response in circulation measured by quantification of inflammatory cell populations
Time frame: 18 months
Safety (adverse events)
Time frame: 18 months
Evaluation of pain (measured by VAS)
Time frame: 18 months
Evaluation of Quality of Life (using a standardized questionnaire)
Time frame: 18 months
Usability of the device as evaluated by treatment logs
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Patient recruitment slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms, run by Clinical Laserthermia Systems AB at 1 site in Germany.
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 7 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 30 Jan 2019. 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 Germany. 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: Patient recruitment slow). 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?
Treatment effect (Measurement of tumor burden by irRC criteria) (time frame: 18 months). 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 30 Jan 2019.