In short
There are currently 2 clinical trials investigating new treatment approaches for Paget's disease of the vulva. These studies are exploring innovative therapies including photodynamic therapy and electrochemotherapy, offering potential alternatives to surgical treatment for this rare condition.
Clinical trial locations
- France
- Italy
Study on the Use of Methyl Aminolevulinate and PAGETEX Device for Treating Vulvar Extra-Mammary Paget's Disease in Women
This clinical trial is being conducted in France and focuses on a novel approach using photodynamic therapy to treat vulvar Paget's disease. The treatment involves a special cream called METVIXIA, which contains methyl aminolevulinate, combined with a medical device called PAGETEX that delivers light therapy.
Who can participate:
- Women aged 18 years or older
- Must have non-invasive vulvar Paget's disease that is either newly diagnosed or has returned after surgery
- A biopsy confirming the diagnosis must have been done within the past year
- Women of childbearing age must use effective contraception during the study
- Must be able to understand the study requirements and attend scheduled visits
- Must have social insurance or be entitled to social security benefits
Who cannot participate:
- Patients without a biopsy-confirmed diagnosis
- Male patients
- Vulnerable populations including children, pregnant women, or those with certain disabilities
What the trial involves:
The main goal of this study is to determine whether the PAGETEX device can help control the disease in at least 30% of patients over three months. During treatment, participants apply the METVIXIA cream to the affected area, and then the PAGETEX device is used to deliver light therapy. This process, known as photodynamic therapy, aims to reduce or eliminate the affected skin areas.
Throughout the study, researchers will monitor the response to treatment by tracking changes in the size and appearance of skin lesions. Regular assessments will also evaluate quality of life, pain levels during treatment sessions, and any side effects. Follow-up visits are scheduled at three and six months to determine treatment effectiveness.
Investigational treatment: The study uses METVIXIA cream containing methyl aminolevulinate along with the PAGETEX photodynamic therapy device. The light activates the cream to target and destroy abnormal cells in the affected area.
Study on Electrochemotherapy with Bleomycin and Cisplatin for Treating Vulvar Paget's Disease and Precancerous Lesions in Newly Diagnosed or Recurrent Patients
This clinical trial is taking place in Italy and explores electrochemotherapy as a treatment option for non-invasive vulvar Paget's disease and certain precancerous lesions. The treatment combines chemotherapy medications with electrical pulses to enhance their effectiveness.
Who can participate:
- Women over 18 years old
- Must have a confirmed diagnosis of either new or returning vulvar disease, including certain precancerous conditions or non-invasive Paget's disease
- Must test positive for high-risk human papillomavirus in the cervix or vagina
- Must have a performance status greater than 70%, meaning they can carry out everyday activities reasonably well
- Must not be suitable candidates for surgery due to disease extent, personal choice, or medical reasons
- Must have a negative pregnancy test
Who cannot participate:
- Male patients
- Patients without the specific types of vulvar lesions or Paget's disease being studied
- Patients outside the specified age range
What the trial involves:
The study evaluates how well electrochemotherapy works in treating these vulvar conditions. Participants receive treatment using two medications, bleomycin and cisplatin, which are administered either intravenously or directly into the affected area. The electrical pulses help the chemotherapy drugs enter cancer cells more effectively.
After treatment, patients are monitored to assess how the lesions respond. An evaluation approximately 30 days after treatment includes tissue examination to determine effectiveness. Follow-up visits are scheduled at one, three, six, and twelve months after treatment to monitor the condition, check for virus persistence, and ensure treatment safety. Participants will complete questionnaires about their symptoms at these intervals. The study is expected to conclude in May 2025.
Investigational treatment: Electrochemotherapy combines chemotherapy drugs bleomycin and cisplatin with electrical pulses to improve treatment outcomes by enhancing drug uptake into abnormal cells.
Summary
Currently, there are two active clinical trials investigating alternative treatments for Paget's disease of the vulva, representing important research efforts for this rare condition. These trials are geographically distributed between France and Italy, each exploring different innovative approaches.
The French trial focuses on photodynamic therapy using the PAGETEX device with methyl aminolevulinate cream, offering a light-based treatment approach. The Italian trial examines electrochemotherapy combining bleomycin and cisplatin with electrical pulses. Both studies aim to provide less invasive treatment options compared to traditional surgery, particularly for patients who may not be suitable surgical candidates or prefer alternative approaches.
Both trials include comprehensive follow-up periods to assess treatment effectiveness, safety, and impact on quality of life. These studies may contribute valuable information about new treatment possibilities for managing this challenging condition.
