Cutaneous Metastases
Conditions
Keywords
Cutaneous metastases
Brief summary
The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.
Detailed description
Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months. It is a non-inferiority study and we accept a difference in response on 15%.
Interventions
Intratumoral injection, once only treatment.
Intratumoral injection, once only treatment
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient and treating doctor only knew the size of the treated tumor, and the injection volume, but not the content of the syringe (either calcium or bleomycin).
Intervention model description
Patients with cutanoues tumors of any cancer histology were included, and metastases were marked, numbered and photographed. Syringes with either calcium or bleomycin were prepared by a pharmacist, blinded for the treating clinician. After injection of study drug (calcium or bleomycin), electroporation was performed. Metastases were followed and at the 6 month follow-up response was recorded for treated metastases and the actual drug used for each metastasis was revealed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years. * Histological confirmed cutaneous metastases of any histology. * At least 1. cutaneous metastases between 0,5 to 3cm, available to electroporation. * Patient should have been offered standard treatment. * At least 2 weeks since chemotherapy or radiotherapy. * Performance status \>2 (ECOG). * Life expectancy \>3 months. * platelet count \> 50 mia/l. * International Normalized Ratio (INR) \<1,2. * Men and women of reproductive age must use effective contraception during the study. * Patient should be able to understand participants information. * Signed, informed consent.
Exclusion criteria
* Previously treatment with bleomycin \> 200.000 Units/m2. * Allergy to bleomycin. * Clinically significant coagulopathy. * Pregnancy or lactation. * Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | After 6 months | Response evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events to calcium electroporation | After 6 months | Describe adverse events using Common Terminology for Adverse Events, version 4.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria. | After 6 months | It is a non-inferiority study, and we accept a difference in response on 15%. |
Countries
Denmark
Outcome results
None listed