Treatment for high-grade vulvar lesions and Paget's disease

Monocentric Phase II Study on the Use of Electrochemotherapy in the Treatment of Paget's Disease and High-grade Squamous Precancerous Lesions or Initially Invasive Vulvar Lesions (GinOnc-ECT Study).

This study is testing if Bleomycin can help adults with high-grade vulvar lesions or Paget's disease who haven't been treated before.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Roma, Lazio)
• Trial ID: NCT06715592 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients diagnosed with high-grade squamous precancerous lesions or non-invasive vulvar Paget's disease who have not received prior treatment. The study will evaluate the efficacy of Bleomycin as an intervention for these conditions. Participants must be over 18 years old and have a Karnofsky performance status greater than 70%. The trial aims to gather data on the safety and effectiveness of this treatment approach in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are postmenopausal Caucasian women with a histological diagnosis of vulvar VIN 2-3 or non-invasive vulvar Paget's disease.

Not a fit: Patients with a diagnosis of adenocarcinoma or those with significant comorbidities such as chronic renal insufficiency or severe respiratory issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-grade vulvar lesions and Paget's disease.

How similar studies have performed: While the rarity of vulvar Paget's disease presents challenges, similar studies targeting precancerous lesions have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Histological diagnosis of de novo or recurrent vulvar VIN 2-3, microinvasive vulvar carcinoma in situ, and non-invasive vulvar Paget's disease
* Positivity for high-risk cervical and/or vaginal HPV
* Age \> 18 years
* Karnofsky performance status \>70%
* Informed consent to participate in the study
* No surgical treatment indication due to disease extension, patient refusal, anesthesiological or reconstructive reasons
* Negative Beta-hCG measurement in urine (pregnancy test or urinary beta-HCG) or in blood (plasma beta-HCG)

Exclusion Criteria:

* Patients with a histological diagnosis of adenocarcinoma
* Patients with concomitant and/or previous tumors
* Current pregnancy and breastfeeding
* Chronic renal insufficiency
* Chronic renal dysfunction
* Patients with a cardiac pacemaker
* Epilepsy
* Lung diseases with moderate/severe respiratory insufficiency
* Poor lung function or abnormal lung function
* Significant coagulation disorders
* Coagulation abnormalities (platelets \< 70,000/mm³ and INR \> 1.5)
* Ongoing HPV vaccination
* Patients with immunosuppressive conditions or treatments (HIV positive)
* Allergy to Bleomycin and/or Cisplatin
* Cumulative doses of 250 mg/m² of Bleomycin received

Where this trial is running

Roma, Lazio

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Lazio, Italy (RECRUITING)

Study contacts

• Principal investigator: Giacomo Corrado — Fondazione Policlinico Universitario A. Gemelli, IRCCS
• Study coordinator: GIACOMO CORRADO, MD

Conditions: Paget Disease of the Vulva, Vulva Cancer