Electrochemotherapy for the Treatment of Vulvar Cancer

NCT05916690 | Unknown

• 1 other identifier: ERID-KSOPKR-0042/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Cancer

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Electrochemotherapy

EXPERIMENTAL

Drug: Electrochemotherapy with bleomycin or cisplatin

Interventions

Electrochemotherapy with bleomycin or cisplatin DRUG

Combination of drug delivery platform (electroporation) and drug (bleomycin)

Electrochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Electrochemotherapy; Bleomycin; Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Maja Cemazar

CONTACT

+386-1-5879-544; mcemazar@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 23, 2023
• Study Start: March 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

SL (1)