Vulval cancer recurrent Trials in Disease

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

This clinical trial is examining a treatment method called electrochemotherapy for women whose vulvar cancer has returned after undergoing multiple treatments. Electrochemotherapy uses electrical pulses to help chemotherapy drugs enter cancer cells more effectively.

Main inclusion criteria:

• Must be a woman aged 18 years or older
• Must have confirmed recurrent vulvar cancer through tissue examination
• Must have previously undergone multiple treatments such as surgery, radiation therapy, or chemoradiation
• Must not be eligible for standard treatments due to reduced daily living abilities (performance status of 3 or higher on the ECOG scale)
• Must have a life expectancy of more than three months
• Must have measurable disease according to standard cancer measurement criteria
• Must have adequate bone marrow, liver, and kidney function as shown by specific blood tests
• Women of childbearing potential must have a negative pregnancy test within 72 hours before starting the study

Main exclusion criteria:

• Having a different type of cancer other than recurrent vulvar cancer
• Not having received multiple treatments previously
• Being male
• Being under 18 or over 65 years of age
• Being part of a vulnerable population requiring special protection or care

Main focus and goal: The trial aims to determine whether using carboplatin and bleomycin together is more effective than using bleomycin alone in preventing the cancer from getting worse. The main goal is to see if the combination treatment can help keep the cancer from progressing for a longer period.

Investigational drugs: The trial is testing two chemotherapy drugs:

• Carboplatin – A platinum-based chemotherapy drug that works by interfering with the DNA in cancer cells, preventing them from growing and dividing. It is administered through an intravenous injection directly into a vein.
• Bleomycin – An antitumor antibiotic that damages the DNA strands of cancer cells, stopping them from multiplying. It is also given through an intravenous injection.

Participants will be randomly assigned to receive either bleomycin alone or a combination of both carboplatin and bleomycin. Throughout the study, patients will have regular follow-up visits to monitor their health and assess how well the treatment is working. The study is expected to continue until April 2027.

Summary

At present, there is one clinical trial available for women with recurrent vulval cancer. This trial is being conducted in Italy and focuses on an innovative approach called electrochemotherapy, which combines electrical pulses with chemotherapy to enhance treatment effectiveness. The study specifically targets patients who have already undergone multiple treatments and are not eligible for standard therapies.

The trial compares the effectiveness of using bleomycin alone versus combining it with carboplatin, both well-established chemotherapy drugs. This research may provide valuable insights into improving treatment options for women facing cancer recurrence after extensive prior therapy.