Electrochemotherapy for the Treatment of Vulvar Cancer

Study Overview
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Brief Summary
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Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.

Official Title
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Electrochemotherapy for the Treatment of Vulvar Cancer

Conditions
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Vulvar Cancer

Intervention / Treatment
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* Drug: Electrochemotherapy with bleomycin or cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Local recurrence of vulvar cancer confirmed by histology The longest diameter of tumor 50 millimeters or less Age more than 18 years Life expectancy of more than 3 months Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale At least 2 weeks have passed since the last treatment The patient must be able to understand the treatment process and possible side effects that may occur during the treatment Signed informed consent form The patient must be presented at a Multidisciplinary Tumor Board Exclusion Criteria: Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases Regional or distant metastases Age less than 18 years Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma) Exposure to cumulative bleomycin doses greater than 400 mg Impaired renal function (Creatinine > 150 µmol/L) Epilepsy Pregnancy Patients who are unable to understand the treatment process or refuse to be involved in the treatment process

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrochemotherapy<br> | Drug: Electrochemotherapy with bleomycin or cisplatin<br>* Combination of drug delivery platform (electroporation) and drug (bleomycin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events 1 month after the treatment | According to CTCAE v5.0 | 1 month | 
| Number of adverse events 2 months after the treatment | According to CTCAE v5.0 | 2 months | 
| Number of adverse events 3 months after the treatment | According to CTCAE v5.0 | 3 months | 
| Number of adverse events 6 months after the treatment | According to CTCAE v5.0 | 6 months | 
| Number of adverse events 9 months after the treatment | According to CTCAE v5.0 | 9 months | 
| Number of adverse events 12 months after the treatment | According to CTCAE v5.0 | 12 months | 
| Efficacy of electrochemotherapy | According to RECIST | 1 month | 
| Efficacy of electrochemotherapy | According to RECIST | 2 months | 
| Efficacy of electrochemotherapy | According to RECIST | 3 months | 
| Efficacy of electrochemotherapy | According to RECIST | 6 months | 
| Efficacy of electrochemotherapy | According to RECIST | 9 months | 
| Efficacy of electrochemotherapy | According to RECIST | 12 months |