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Study on Electrochemotherapy with Bleomycin and Cisplatin for Treating Vulvar Paget's Disease and Precancerous Lesions in Newly Diagnosed or Recurrent Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called electrochemotherapy for certain conditions affecting the vulva. The conditions being studied include Paget's disease and high-grade or initially invasive precancerous squamous lesions of the vulva. These are types of skin changes that can occur in the vulvar area, which is part of the female reproductive system. The treatment involves using two medications, Bleomycin and Cisplatin, which are administered in combination with electrical pulses to enhance their effectiveness.

The purpose of the study is to evaluate how well electrochemotherapy works in treating these vulvar conditions. Participants in the study will receive the treatment and will be monitored over a period of time to assess the response of the lesions to the treatment. The study will also look at the safety of the treatment and how long the disease remains under control after treatment. Participants will be asked to complete questionnaires about their symptoms before and after the treatment at various intervals, including one, three, six, and twelve months after the treatment.

This study aims to provide valuable information on the effectiveness and safety of electrochemotherapy for treating vulvar lesions and non-invasive Paget's disease, potentially offering a new treatment option for these conditions. The study is expected to continue until May 2025, with recruitment having started in March 2023.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of vulvar lesions or Paget's disease.

    A consent form is signed to confirm understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the vulvar lesions or Paget's disease.

    This includes a physical examination and possibly imaging tests to document the extent of the disease.

  3. Step 3

    Electrochemotherapy treatment

    The treatment involves the use of electrochemotherapy, which combines chemotherapy drugs with electrical pulses to enhance drug uptake by cancer cells.

    The drugs used are bleomycin and cisplatin, administered either intravenously or directly into the tumor.

    The specific dosage and frequency are determined by the medical team based on individual patient needs.

  4. Step 4

    Post-treatment evaluation

    Approximately 30 days after the treatment, an evaluation is conducted to assess the response of the lesions to the therapy.

    This involves a histological examination of surgical specimens to determine the effectiveness of the treatment.

  5. Step 5

    Follow-up visits

    Follow-up visits are scheduled at one, three, six, and twelve months after treatment to monitor the patient's condition.

    During these visits, assessments include checking for HPV persistence, evaluating symptom changes, and ensuring the safety of the treatment method.

  6. Step 6

    Completion of study participation

    The study is expected to conclude by May 31, 2025, at which point all data will be analyzed to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of either new or returning squamous disease of the vulva, which includes VIN 2-3 (a type of precancerous condition), microinvasive carcinoma in situ (a very early stage of cancer), or noninvasive vulvar Paget's disease.
  • Must test positive for high-risk human papillomavirus (HR HPV) in the cervix or vagina. HR HPV is a virus that can cause changes in cells.
  • Must be over 18 years old.
  • Must have a **Karnofsky performance status** greater than 70%. This is a scale that measures a person's ability to perform everyday activities, with higher numbers indicating better ability.
  • Must agree to participate in the study by providing informed consent, which means understanding the study and agreeing to take part.
  • Must not have a need for surgery due to the extent of the disease, personal choice, or reasons related to anesthesia or reconstruction.
  • Must have a negative pregnancy test, either through urine or blood, to confirm they are not pregnant.

Who cannot join the trial?

4 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva cannot participate.
  • Patients who do not have non-invasive vulvar Paget's disease cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
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Investigated drugs

Electrochemotherapy is a treatment that combines chemotherapy with electrical pulses to enhance the effectiveness of the chemotherapy drugs. In this trial, it is being used to treat vulvar lesions and non-invasive Paget's disease. The electrical pulses help the chemotherapy drugs to enter the cancer cells more effectively, potentially improving the treatment outcomes for these conditions.

What is already known about the treatment

Electrochemotherapy – This treatment is administered through a combination of chemotherapy and electrical pulses directly applied to the affected area. It is currently being studied in clinical trials for its effectiveness in treating high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease. The main therapeutic indication is for patients with these specific vulvar conditions. The mechanism of action involves enhancing the uptake of chemotherapeutic drugs into cancer cells by temporarily increasing cell membrane permeability through electrical pulses. Electrochemotherapy is classified under local cancer treatments, combining physical and chemical methods to target tumor cells.

Investigated diseases

  • High-Grade Squamous Intraepithelial Lesions of the Vulva

    These are abnormal growths on the vulva that can potentially progress to cancer if left untreated. They are characterized by changes in the cells lining the vulva, often caused by persistent infection with human papillomavirus (HPV). These lesions may not cause symptoms initially, but as they progress, they can lead to itching, discomfort, or visible changes in the vulvar skin. Monitoring and management are crucial to prevent progression to invasive cancer.

  • Non-Invasive Vulvar Paget's Disease

    This is a rare skin condition affecting the vulva, characterized by the presence of cancerous cells confined to the top layer of the skin. It often presents as red, scaly, and itchy patches on the vulva, resembling eczema or dermatitis. The disease progresses slowly and remains limited to the skin without invading deeper tissues. It is important to differentiate it from other skin conditions for appropriate management.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518796-65-00Protocol codeGinOnc-ECTEstimated enrolment18 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

sourced from the EU Clinical Trials Register and site verification

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