Cutaneous or subcutaneous malignant tumours 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 desc
Sponsors
Julie Gehl
Eligibility
Sex/Gender
All
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 must have been offered other relevant standard treatment for their cancer disease. • The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more. • The patient can undergo radiation therapy, provided that the treatment field does not involve treated area. • Performance status ECOG/WHO =2. • At least one cutaneous or subcutaneous tumour measuring up to 3 cm. • 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. The evaluation will use the modified RECIST criteria, clinical examination with calliper measurement and photographical documentation using adhesive rulers for scale. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions.; Secondary Objective: Secondary endpoints are to • Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months. • Assess tumour and surrounding tissue response to treatment from biopsies of the treated area after 1 year. • Assess response after treatment on MRI scans on a subset of patients before and immediately after treatment, as well as after 2 months. • Evaluate patient quality of life before treatment, after 2 months and after 1 year through o EORTC questionnaires. o Qualitative interviews (in a subset of patients). • Investigate any sign of systemic immunologic response from any routine scans before and after treatment in the inclusion period. • To list response rates and response duration according to tumour histology. • To determine complete and partial remissions for all tumours treated. • To determine rate of response for each individual patient. ;Primary end point(s): The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. The evaluation will use the modified RECIST criteria, clinical examination with calliper measurement and photographical documentation using adhesive rulers for scale. Response rate will be defined as number o | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are to • Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months. • Assess tumour and surrounding tissue response to treatment from biopsies of the treated area after 1 year. • Assess response after treatment on MRI scans on a subset of patients before and immediately after treatment, as well as after 2 months. • Evaluate patient quality of life before treatment, after 2 months and after 1 year through o EORTC questionnaires. o Qualitative interviews (in a subset of patients). • Investigate any sign of systemic immunologic response from any routine scans before and after treatment in the inclusion period. • To list response rates and response duration according to tumour histology. • To determine complete and partial remissions for all tumours treated. • To determine rate of response for each individual patient. • To investigate response (overall, as well as complete and partial) depending whether the treated tumour was in a previously irradiated area • To measure current during treatment as measured by the pulse generator. ;Timepoint(s) of evaluation of this end point: • Evaluate treatment response at month 1, 3, 4, 6 and 12 in addition to evaluating treatment response after 2 months. | — |
Countries
Denmark, Germany
Contacts
Public ContactMille Vissing
Region Zealand
Outcome results
None listed