Cutaneous metastases from solid cancer of any histology MedDRA version: 21.1 Level: LLT Classification code 10026693 Term: Malignant skin neoplasm NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Calcium chloride SAD
Pharmaceutical Form: Solution for injection
INN or Proposed INN: calcium chloride dihydrate in sterile water
Other descriptive name: CALCIUM CHLORIDE
Concentration uni
Sponsors
Julie Gehl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Trial subject = 18 years. • Trial subject must be able to understand the participant information. • Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. • The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.). • The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area. • Performance status ECOG/WHO =2 • At least one cutaneous or subcutaneous tumour measuring at least 5 mm. • Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.) • Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Exclusion criteria • Pregnancy or lactation • Allergy to local anaesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment (biopsy taken on the day of treatment before the calcium electroporation procedure). TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.;Secondary Objective: Secondary endpoints include: Secondary endpoints are: • To investigate the adaptive tumour immune response by different methods including, protein expression levels of immune markers, tumour inflammation signature (TIS) score and molecular subtype classification. • To clinically evaluate treatment response 1, 2 and 3 months after treatment measuring changes in size of the treated lesions. • To describe any relation between change in TIL population and tumour type. • To assess regressive changes including necrosis. • To establish number of treated tumours with complete response depending on tumour type. • To detect signs of systemic immunologic response from any routine scans before and after treatment in the inclusion period. • To investigate differences in effect depending whether the treated tumour was in a previously irradiated area. • To evaluate effect on adjacent non-tumour tissue. • To assess PD-L1 expression over time by biopsy. ;Primary end point(s): The primary endpoint of this study is change in TIL population before versus two days after calcium electroporation. TIL content will be measured in % (range 0-100%). One-way ANOVA will be used for analysis to assess differences in TIL content before and 2 days after treatment in all metastases and in subgroups based on cancer type. ;Timepoint(s) of evaluation of this end point: Two days compared to before treatment (day 0) biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: • To investigate the adaptive tumour immune response by different methods including, protein expression levels of immune markers, tumour inflammation signature (TIS) score and molecular subtype classification. • To clinically evaluate treatment response 1, 2 and 3 months after treatment measuring changes in size of the treated lesions. • To describe any relation between change in TIL population and tumour type. • To assess regressive changes including necrosis. • To describe presence of residual tumour and its topographical location. • To investigate vascular effects of calcium electroporation including changes in capillary structures. • To document tumours before and after treatment using digital photography including a ruler. • To establish number of treated tumours with complete response after one or two treatments, respectively. • To establish number of treated tumours with complete response depending on tumour type. • To detect signs of systemic immunologic response from any routine scans before and after treatment in the inclusion period. • To investigate differences in effect depending whether the treated tumour was in a previously irradiated area. • To evaluate effect on adjacent non-tumour tissue. • To assess PD-L1 expression over time by biopsy. • To investigate any relation between change in PD-L1 expression and tumour response. • To describe PD-L1 expression in relation to cell types found in the tumour environment. • To describe PD-L1 expression on different cell types of the different tumour histologies investigated. • To examine frozen tissues samples by e.g. western blotting and PCR in order to support any of the above mentioned endpoints. • To examine blood samples for immune factors and other relevant markers, and compare levels before and after treatment. • To measure current during treatment as indicated by the pulse generator. ;Timepoint(s) of evaluation of this end point: Th | — |
Countries
Denmark
Contacts
Public ContactMille Vissing
Zealand University Hospital
Outcome results
None listed