Reducing Bleomycin in Electrochemotherapy for Skin Tumors

Randomised Controlled Clinical Trial Investigating the Effect of Reduced Bleomycin in Elechtrochemotherapy Treatment on Patients With Cutaneous Malignancies (The BLESS Trial)

This study is testing if using a lower dose of bleomycin during electrochemotherapy is just as effective for treating skin tumors as the usual higher dose.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zealand University Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Herlev and 1 other locations)
• Trial ID: NCT06647342 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate whether a reduced dose of bleomycin in electrochemotherapy is as effective as the standard dose for treating various skin tumors. Electrochemotherapy combines chemotherapy with electrical pulses to enhance drug delivery into tumor cells. Participants will receive either half or the full standard dose of bleomycin during a single electrochemotherapy session, with tumor size measured before and three months after treatment. Follow-up visits will monitor tumor response, adverse events, and quality of life.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically verified cutaneous or subcutaneous cancer.

Not a fit: Patients with tumors that have previously received electrochemotherapy or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to effective treatment of skin tumors with fewer side effects from chemotherapy.

How similar studies have performed: Other studies have shown promising results with electrochemotherapy, but this specific approach of dose reduction is novel.

Eligibility criteria

Inclusion Criteria:

1. Trial subject \> 18 years.
2. Trial subject must be able to understand the participant information.
3. Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
4. Life expectancy \> 3 months.
5. Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study.
6. 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.
7. 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.
8. 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.
9. 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.
10. Signed informed consent.

Exclusion Criteria:

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

Where this trial is running

Herlev and 1 other locations

• Copenhagen University Hospital Herlev-Gentofte — Herlev, Denmark (Recruiting)
• Zealand University Hospital — Roskilde, Denmark (Recruiting)

Study contacts

• Study coordinator: Julie Gehl, MD, Dr.Med.

Conditions Cutaneous Metastasis; Cutaneous Malignant Mixed Tumor; Bleomycin Adverse Reaction; Electrochemotherapy; Deescalating study; Bleomycin; Cutaneous malignancies; Cutaneous tumors