RECRUITING Phase 4 ClinicalTrials.gov

The Effect of Reduced Bleomycin in Electrochemotherapy Treatment

Sponsor: Julie Gehl • ClinicalTrials.gov ID: NCT06647342

Registry updated: 2026-09-15

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Description

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.

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.

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.

Conditions

Cutaneous Metastasis Cutaneous Malignant Mixed Tumor Bleomycin Adverse Reaction Electrochemotherapy

Locations

Copenhagen University Hospital Herlev-Gentofte — Herlev, Denmark
Zealand University Hospital — Roskilde, Denmark

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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