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The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium electroporation | Experimental | The metastases will be treated with intratumoral injection of calcium chlorid followed by electrotransfer. It is a once-only treatment. Calcium chlorid concentration: 9mg/ml. Total dose: 0,5ml/cm3 tumor volume. |
|
| Electrochemotherapy with bleomycin | Active Comparator | The metastases will be treated with intratumoral injection of bleomycin followed by electrotransfer. It is a once only treatment. bleomycin concentration: 1000 IU/ml. Total dose: o,5 ml/cm3 tumor volume. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium electroporation | Drug | Intratumoral injection, once only treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1. | After 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events to calcium electroporation | Describe adverse events using Common Terminology for Adverse Events, version 4.0 | After 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria. | It is a non-inferiority study, and we accept a difference in response on 15%. | After 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Gehl | Department of Oncology, Copenhagen University hospital, Herlev | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Copenhagen University Hospital, Herlev | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28562201 | Background | Falk H, Lambaa S, Johannesen HH, Wooler G, Venzo A, Gehl J. Electrochemotherapy and calcium electroporation inducing a systemic immune response with local and distant remission of tumors in a patient with malignant melanoma - a case report. Acta Oncol. 2017 Aug;56(8):1126-1131. doi: 10.1080/0284186X.2017.1290274. Epub 2017 Feb 22. No abstract available. | |
| 28816072 |
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| ID | Term |
|---|---|
| D002122 | Calcium Chloride |
| D053672 | Electrochemotherapy |
| D001761 | Bleomycin |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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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.
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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).
| Electrochemotherapy with bleomycin | Drug | Intratumoral injection, once only treatment |
|
|
| Falk H, Matthiessen LW, Wooler G, Gehl J. Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy. Acta Oncol. 2018 Mar;57(3):311-319. doi: 10.1080/0284186X.2017.1355109. Epub 2017 Aug 17. |
| D017606 |
| Chlorine Compounds |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000092722 | Electroporation Therapies |
| D018274 | Electroporation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |