The Effect of Reduced Bleomycin in Electrochemotherapy Treatment

NCT06647342 | Recruiting Phase 4

• 2 other identifiers: CTIS: 2024-513360-25-002024-513360-25-00
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors. Electrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively. Participants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.

Conditions

Cutaneous Metastasis; Cutaneous Malignant Mixed Tumor; Bleomycin Adverse Reaction; Electrochemotherapy

Keywords

Deescalating study; Bleomycin; Electrochemotherapy; Cutaneous malignancies; Cutaneous tumors

Outcome Measures

Primary Outcomes (1)

• To evaluate the clinical overall response rate of electrochemotherapy treatment of cutaneous malignancies after three months

  The response to treatment will be evaluated according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Response rate will be defined as the number of responding tumours relative to the number of treated tumours (Intention to treat analysis, ITT), evaluated 3 months after treatment. The response will be evaluated by clinical examination with ruler measurements (in mm) and photographical documentation using rulers for scale.

  The tumors will be meassured before electrochemotherapy (baseline) and three months after electrochemotherapy treatment.

Secondary Outcomes (17)

• Treatment response for normal dose group, reduced dose group, and for all treated tumors at optimnal time points using the mRECIST criteria.

  The follow up is mandatory for the patients after 2 weeks, after 3 months and 12 months. Follow up is optional at 1 month, 2 moths, 4 moths and 6 months. At every visit the tumours size will be measured.

• Aesthetic outcome for normal dose group, reduced dose group and for all tumours 3 months after treatment and 1 year after treatment, using the Vancouver Scar Scale.

  Assessed 3 months after treatment and 1 year after treatment.

• Aesthetic outcome for normal dose group, reduced dose group and for all tumors assessed at 3 month and 12 month, using Patient and Observer Scar Assessment Scale (POSAS).

  3 months ater treatment and 1 year after treatment.

• Complete and partial remissions for all patients treated (patient level)

  Before treatment (baseline) compared to 3 months after treatment.

• Biopsy at 12 months (optional) for histological examination of malignancy presence (HE stain, and staining for specific tumour markers can be included).

  12 months

Study Arms (2)

Standard dose

ACTIVE COMPARATOR

Patients in this arm will recieve the standard dose of bleomycin during treatment with electrochemotherapy

Drug: Bleomycin

Dose reduction

EXPERIMENTAL

Patients in this arm will recieve half the standard dose of bleomycin during treatment with electrochemotherapy

Drug: Bleomycin

Interventions

Bleomycin DRUG

In the standard arm, Bleomycin (Baxter, Germany) at a dose of 15.000 IU/m² is used. In the dose reduction arm, a dose of 7500 IU/m² is used. Note that in Denmark bleomycin is dosed by international units, whereas other countries may use respectively U (units) or mg.

Dose reduction; Standard dose

Eligibility Criteria

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

You may qualify if:

• Trial subject \> 18 years.
• Trial subject must be able to understand the participant information.
• Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
• Life expectancy \> 3 months.
• Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study.
• Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed.
• Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed.
• A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance \> 50 ml/min.
• Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization.
• Signed informed consent.

You may not qualify if:

• Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment.
• Allergy or hypersensitivity to bleomycin.
• Acute lung infection.
• Severely impaired lung function or any lung condition the investigator deems severe.
• Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit.
• The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.

Sponsors & Collaborators

• Julie Gehl: lead
• Roskilde University: collaborator
• Herlev Hospital: collaborator

Study Sites (2)

Copenhagen University Hospital Herlev-Gentofte

Herlev, 2730, Denmark

RECRUITING

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Related Publications (1)

• Bastrup FA, Vissing M, Gehl J. Electrochemotherapy for metastatic cutaneous melanoma. Acta Oncol. 2022 May;61(5):531-532. doi: 10.1080/0284186X.2022.2057199. Epub 2022 Apr 29. No abstract available.

  PMID: 35484987 BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Julie Gehl, Professor, MD

  Department of Oncology and Palliative Care, Zealand University Hospital, Denmark

  STUDY CHAIR

Central Study Contacts

Julie Gehl, MD, Dr.Med.

CONTACT

4593577626; kgeh@regionsjaelland.dk

Marie Tolstrup, MD

CONTACT

4561548049; maato@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators analysing bleomycin concentrations using HPLC.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Double-blinded randomized controlled study

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 17, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study protocol will be immediately available, and a protocol article will be written.
• Access Criteria: Information regarding study protocol will be directly available from the investigator. Results from the study will be published in a peer reviewed international journal. Pseudoanonymized data will be uploaded to the Inspect database, but not otherwise be made available.

Locations

DK (2)