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Study on Electrochemotherapy with Carboplatin and Bleomycin for Women with Relapsed Vulvar Cancer After Multiple Treatments

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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 a type of cancer called vulvar cancer, which affects the external part of the female genital organs. The study is specifically looking at cases where the cancer has returned after multiple treatments. The trial is testing a treatment method called electrochemotherapy, which combines electrical pulses with chemotherapy drugs to help the drugs enter cancer cells more effectively. The medications being tested in this study are Bleomycin and Carboplatin. Bleomycin is a drug that is injected into the bloodstream to help stop cancer cells from growing. Carboplatin is another drug used in chemotherapy that is also given through an injection.

The purpose of this study is to find out if using both Carboplatin and Bleomycin together is more effective than using Bleomycin alone in preventing the cancer from getting worse. Participants in the study will receive either the combination of Carboplatin and Bleomycin or just Bleomycin. The study will take place over a period of time, with regular check-ups to monitor the progress of the treatment. The treatment will be given through an intravenous injection, which means it will be administered directly into a vein.

Throughout the study, participants will be closely monitored to see how well the treatment is working and to check for any side effects. The main goal is to see if the combination treatment can help keep the cancer from progressing for a longer period compared to using Bleomycin alone. This study aims to provide valuable information that could improve treatment options for women with relapsed vulvar cancer.

The research process

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

Step 1
Enrollment
Upon joining the study, you will be required to provide a signed informed consent. This confirms your understanding and willingness to participate in the study.
A negative pregnancy test is required for females of childbearing potential within 72 hours before the first day of the study.
Step 2
Initial assessment
You will undergo a series of tests to confirm eligibility, including blood tests to check bone marrow, liver, and kidney function. These tests must be completed within 15 days before the treatment begins.
Your medical history will be reviewed to ensure you meet the study criteria, such as having relapsing vulvar carcinoma and having undergone multiple treatments.
Step 3
Treatment allocation
You will be randomly assigned to one of two treatment groups: one receiving bleomycin alone, and the other receiving a combination of bleomycin and carboplatin.
Step 4
Treatment administration
If you are in the bleomycin group, you will receive bleomycin sulfate as a solution for injection through an intravenous route.
If you are in the combination group, you will receive both bleomycin sulfate and carboplatin as solutions for infusion through an intravenous route.
The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.
Step 5
Monitoring and follow-up
Throughout the study, you will have regular follow-up visits to monitor your health and the effects of the treatment.
Your progress will be assessed to determine the effectiveness of the treatment in preventing local progression of the cancer.
Step 6
Study completion
The study is expected to continue until April 8, 2027. Your participation will be monitored until the study's conclusion or until you decide to withdraw.
Upon completion, you will receive information about the study results and any further steps regarding your treatment.

Who can join the trial?

14 criteria

Must be a woman aged 18 years or older.
Must have a confirmed diagnosis of recurrent vulvar carcinoma (a type of cancer) through a tissue examination.
Must have undergone multiple treatments such as surgery and radiation therapy or chemoradiation, or a combination of these with chemotherapy.
Must not be eligible for standard treatments like surgery, radiation therapy, and systemic chemotherapy due to a performance status of 3 or higher on the ECOG scale (a measure of daily living abilities).
Must have a life expectancy of more than three months.
Must have a measurable disease according to RECIST 1.1 (a standard way to measure cancer response to treatment).
check
Must have adequate bone marrow, liver, and kidney function as shown by specific blood test results:
- Hemoglobin level of at least 8.0 g/dL (with or without blood transfusion).
- Platelet count of at least 75 x 10⁹/L.
- INR (a blood clotting test) greater than 1.5.
- AST/SGOT and ALT/SGPT (liver enzymes) no more than 3 times the upper limit of normal.
- Total bilirubin (a liver function test) no more than 2 times the upper limit of normal, or 3 times for those with Gilbert’s syndrome.
- Serum creatinine (a kidney function test) less than 1.5 mg/dL and creatinine clearance greater than 30 ml/min.
- For women who can have children, a negative pregnancy test is required within 72 hours before starting the study.
- Must provide signed informed consent before starting any study-specific procedures, indicating understanding and willingness to participate in the study.

Who cannot join the trial?

5 criteria

Patients who have a **different type of cancer** other than relapsing vulvar carcinoma.
Patients who have not received **multiple treatments** for their vulvar carcinoma.
Patients who are **male**.
Patients who are **under the age of 18** or **over the age of 65**.
Patients who are part of a **vulnerable population**, which means they might need special protection or care.

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Verified sites

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Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy

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Investigated drugs

Carboplatin
is a type of chemotherapy drug used to treat various cancers. It works by interfering with the DNA in cancer cells, which prevents them from growing and dividing. In this trial, Carboplatin is being used in combination with another drug to see if it can help improve outcomes for patients with vulvar cancer.
Bleomycin
is another chemotherapy medication that is used to treat different types of cancer. It works by damaging the DNA in cancer cells, which can stop them from multiplying. In this study, Bleomycin is being tested both on its own and in combination with Carboplatin to determine its effectiveness in treating vulvar cancer.

What is already known about the treatment

Carboplatin
Carboplatin is administered through an injection into a vein, typically in a hospital or clinic setting. It is currently being studied in combination with Bleomycin for treating relapsing vulvar carcinoma that has already been subjected to multiple treatments. The main therapeutic indication is to improve local progression-free survival in women with this type of cancer. At the molecular level, Carboplatin works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified as a platinum-based chemotherapy drug.
Bleomycin
Bleomycin is also administered via injection, often in a clinical setting, and is being evaluated both alone and in combination with Carboplatin for treating relapsing vulvar carcinoma. Its primary use in this context is to help control the progression of cancer that has not responded to other treatments. Bleomycin acts by causing breaks in the DNA strands of cancer cells, which inhibits their ability to multiply. It is classified as an antitumor antibiotic.

Investigated diseases

Vulvar Carcinoma – Vulvar carcinoma is a type of cancer that occurs on the outer surface area of the female genitalia. It typically begins as a slow-growing lesion or sore on the vulva, which may initially appear as a lump or ulcer. Over time, the cancer can invade deeper layers of skin and spread to nearby tissues, including lymph nodes. The progression of the disease can lead to symptoms such as itching, pain, or bleeding in the affected area. As the carcinoma advances, it may cause changes in the appearance of the vulva, such as thickening or color changes. The disease is often diagnosed after it has recurred following initial treatments like surgery and radiotherapy.