Electrochemotherapy for the Treatment of Vulvar Cancer

Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Cancer
• Intervention / Treatment: Drug: Electrochemotherapy with bleomycin or cisplatin

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maja Cemazar; Phone Number: +386-1-5879-544; Email: mcemazar@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Maja Cemazar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Local recurrence of vulvar cancer confirmed by histology
2. The longest diameter of tumor 50 millimeters or less
3. Age more than 18 years
4. Life expectancy of more than 3 months
5. Performance status according to Karnofsky ≥ 70 or < or 2 according to the WHO scale
6. At least 2 weeks have passed since the last treatment
7. The patient must be able to understand the treatment process and possible side effects that may occur during the treatment
8. Signed informed consent form
9. The patient must be presented at a Multidisciplinary Tumor Board

Exclusion Criteria:

1. Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
2. Regional or distant metastases
3. Age less than 18 years
4. Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
5. Exposure to cumulative bleomycin doses greater than 400 mg
6. Impaired renal function (Creatinine > 150 µmol/L)
7. Epilepsy
8. Pregnancy
9. Patients who are unable to understand the treatment process or refuse to be involved in the treatment process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrochemotherapy	Drug: Electrochemotherapy with bleomycin or cisplatin; Combination of drug delivery platform (electroporation) and drug (bleomycin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events 1 month after the treatment	According to CTCAE v5.0	1 month
Number of adverse events 2 months after the treatment	According to CTCAE v5.0	2 months
Number of adverse events 3 months after the treatment	According to CTCAE v5.0	3 months
Number of adverse events 6 months after the treatment	According to CTCAE v5.0	6 months
Number of adverse events 9 months after the treatment	According to CTCAE v5.0	9 months
Number of adverse events 12 months after the treatment	According to CTCAE v5.0	12 months
Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	1 month
Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	2 months
Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	3 months
Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	6 months
Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	9 months
Response of the tumor to electrochemotherapy according to RECIST criteria	According to RECIST criteria	12 months

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Neoplasms; Antineoplastic Agents; Antibiotics, Antineoplastic; Bleomycin
• Other Study ID Numbers: ERID-KSOPKR-0042/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No