The Effect of Reduced Bleomycin in Electrochemotherapy Treatment

Launched by JULIE GEHL · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether using a lower dose of a chemotherapy drug called bleomycin, combined with a treatment called electrochemotherapy, is just as effective as using the standard dose for treating certain skin tumors. Electrochemotherapy works by delivering chemotherapy directly to the tumor and then applying a quick electrical pulse, which helps the chemotherapy enter the tumor cells more effectively. The trial will involve participants receiving either half or the full standard dose of bleomycin during a single treatment session. Researchers will measure the size of the tumors before and three months after treatment to see how well each dose works.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of skin cancer. They should be in good enough health to have a life expectancy of at least three months, and they can still receive other treatments for their cancer during the study. Participants will need to attend follow-up visits at two weeks, three months, and a year after treatment to monitor their progress and any side effects. It’s important for individuals interested in this trial to discuss it with their doctor to see if they meet all the criteria and to understand what to expect.

Gender

ALL

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.