Reducing Bleomycin in Electrochemotherapy for Skin Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Julie Gehl, MD, Dr.Med.
• Email: kgeh@regionsjaelland.dk
• Phone: 4593577626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.