Electrochemotherapy for the Treatment of Vulvar Cancer

• Sponsor: Institute of Oncology Ljubljana (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05916690
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 58
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Cancer	Drug: Electrochemotherapy with bleomycin or cisplatin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Electrochemotherapy for the Treatment of Vulvar Cancer
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of adverse events 1 month after the treatment [1 month]

   According to CTCAE v5.0

2. Number of adverse events 2 months after the treatment [2 months]

   According to CTCAE v5.0

3. Number of adverse events 3 months after the treatment [3 months]

   According to CTCAE v5.0

4. Number of adverse events 6 months after the treatment [6 months]

   According to CTCAE v5.0

5. Number of adverse events 9 months after the treatment [9 months]

   According to CTCAE v5.0

6. Number of adverse events 12 months after the treatment [12 months]

   According to CTCAE v5.0

7. Efficacy of electrochemotherapy [1 month]

   According to RECIST

8. Efficacy of electrochemotherapy [2 months]

   According to RECIST

9. Efficacy of electrochemotherapy [3 months]

   According to RECIST

10. Efficacy of electrochemotherapy [6 months]

    According to RECIST

11. Efficacy of electrochemotherapy [9 months]

    According to RECIST

12. Efficacy of electrochemotherapy [12 months]

    According to RECIST

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. Exposure to cumulative bleomycin doses greater than 400 mg

2. Impaired renal function (Creatinine > 150 µmol/L)

3. Epilepsy

4. Pregnancy

5. Patients who are unable to understand the treatment process or refuse to be involved in the treatment process

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Oncology Ljubljana	Ljubljana		Slovenia

Sponsors and Collaborators

• Institute of Oncology Ljubljana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Oncology Ljubljana
• ClinicalTrials.gov Identifier: NCT05916690
• Other Study ID Numbers: ERID-KSOPKR-0042/2021
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vulvar Neoplasms; Bleomycin

Study Results

No Results Posted as of Jun 23, 2023