Electrochemotherapy of Gynecological Cancers

NCT04760327 | Recruiting Phase 2 DMC

• 1 other identifier: 0120-692/2017/4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.

Conditions

Gynecological Cancers

Keywords

Electrochemotherapy; Cisplatin; Bleomycin

Outcome Measures

Primary Outcomes (1)

• Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.

  Effectiveness of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Effectiveness will be evaluated according to RECIST 1.1 criteria.

  Changes from baseline regularly up to 24 months

Secondary Outcomes (1)

• Safety of electrochemotherapy according to CTCAE v5.0 criteria.

  during hospitalization and up to 24 months

Study Arms (1)

Electrochemotherapy of gynecological cancers

EXPERIMENTAL

Combination Product: Electrochemotherapy with bleomycin or cisplatin

Interventions

Electrochemotherapy with bleomycin or cisplatin COMBINATION_PRODUCT

Electrochemotherapy with cisplatin or bleomycin of gynecological cancers

Also known as: Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)

Electrochemotherapy of gynecological cancers

Eligibility Criteria

• Age: 18 Years - 105 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
• Age more than 18.
• Life expectancy more than 3 month.
• Performance status Karnofsky ≥ 70 or WHO \< or 2.
• Treatment free interval minimum 2 weeks.
• Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
• Patient must give informed consent.
• Patient must be discussed at the multidisciplinary team before entering the trial.
• Patient should be suitable for anesthesia.

You may not qualify if:

• Visceral, bone or diffuse metastases.
• Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
• Significant reduction in respiratory function.
• Age less than 18 years.
• Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
• Cumulative dose of ≥ 400 mg/m2 bleomycin received.
• Impaired kidney function (creatinin \> 150 µmol/l).
• Patients with epilepsy.
• Pregnancy.
• Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of oncology Ljubljna

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Interventions

Electrochemotherapy; Bleomycin; Cisplatin; Electroporation; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; 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

Gregor Serša, PhD

CONTACT

+386 1 5879 434; gsersa@onko-i.si

Maja Čemažar, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: February 18, 2021
• Study Start: July 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

SL (1)