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Study on Reducing Bleomycin Dose in Electrochemotherapy for Patients with Skin Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The BLESS Trial is a study focused on treating patients with cutaneous malignancies, which are types of cancer that affect the skin. The treatment being studied is called electrochemotherapy, which combines a medication named bleomycin with electrical pulses to help the drug enter cancer cells more effectively. The purpose of this study is to see if using a reduced dose of bleomycin can still provide a good response in shrinking or controlling the tumors.

Participants in the study will receive either the standard dose or a reduced dose of bleomycin as part of their electrochemotherapy treatment. The study will monitor how well the tumors respond to the treatment over time, as well as any changes in the appearance of the skin and overall quality of life. The study will also look at the side effects experienced by participants and how these might differ between the two dosage groups.

The study will last for several months, with regular check-ups to assess the treatment's effectiveness and any side effects. Participants may also have optional follow-up tests, such as biopsies, to further understand the treatment's impact on the cancer. The goal is to determine if a lower dose of bleomycin can be just as effective, potentially reducing side effects while maintaining the treatment's benefits.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's objectives and procedures. The participant must provide signed informed consent, confirming understanding of the study details.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying the presence of cutaneous malignancies and ensuring a life expectancy of more than three months. Blood tests will be performed to check creatinine levels, which should be within normal limits or have a creatinine clearance greater than 50 ml/min.
Step 3
Treatment administration
The treatment involves the administration of bleomycin intravenously. The study aims to evaluate if the standard dose can be reduced by 50% while maintaining effectiveness. The exact dosage and frequency will be determined based on the group assignment (normal dose or reduced dose).
Step 4
Monitoring and follow-up
Participants will be monitored for treatment response using criteria such as RECIST, digital photography, and ruler measurements. The primary endpoint is to assess the overall response rate after three months.
Secondary assessments include aesthetic outcomes, complete and partial remissions, and quality of life evaluations using the EORTC questionnaire C30. Optional biopsies may be conducted after 12 months for further analysis.
Step 5
Evaluation of side effects
Side effects will be monitored and recorded according to the CTCAE criteria. The emergence of pain due to cutaneous malignancies will be assessed using the Numeric Rating Scale (NRS).
Step 6
Pharmacokinetics and concentration analysis
Blood samples will be collected at various intervals (0, 5, 10, 20, 30, and 40 minutes) after bleomycin infusion to analyze pharmacokinetics. The concentration of bleomycin in the tumour will also be measured to understand its distribution and effectiveness.
Step 7
Study completion
The study is expected to conclude by July 2, 2027. Participants will have completed all required assessments and follow-ups by this date.

Who can join the trial?

10 criteria

The person must be older than 18 years.
The person must sign a document called an informed consent, which means they agree to participate after understanding the study details.
The person must be able to understand the information given about the study.
The person must have a type of cancer that affects the skin or tissue just under the skin, confirmed by a test called a histology.
The person should have a life expectancy of more than 3 months.
The person can receive other medical treatments like hormone therapy, chemotherapy, or immunotherapy during the study.
The person may have had a treatment called ECT (electrochemotherapy) before, as long as the tumors being studied have not been treated with ECT, or if at least 3 months have passed since the last ECT treatment.
The person can have radiation therapy, as long as it does not affect the area being treated in the study. If radiation therapy was given to the area being treated, at least 3 months should have passed.
The person must have a normal level of a substance called creatinine in their blood. If the creatinine level is higher than normal, their kidneys must still be working well enough, with a creatinine clearance greater than 50 ml/min.
Both men and women who are sexually active must use reliable birth control methods. This includes using devices like an intrauterine device (IUD), taking birth control pills, using male or female condoms, or having procedures like vasectomy or female sterilization.

Who cannot join the trial?

1 criterion

Patients with **any cancer that involves the skin** cannot participate. This means if you have a type of cancer that affects your skin, you are not eligible.

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Verified sites

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Verified
Herlev Hospital
Herlev, Denmark

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Investigated drugs

Bleomycin is a medication used in this trial as part of electrochemotherapy treatment for patients with skin cancers. The study is exploring whether the amount of bleomycin can be reduced by half while still maintaining its effectiveness in treating tumors.

Bleomycin

What is already known about the treatment

Bleomycin – Bleomycin is administered through injection, often used in combination with electrochemotherapy for treating skin-related cancers. It is currently being studied to determine if its dosage can be reduced while maintaining effectiveness in treating cutaneous malignancies. The main therapeutic use of bleomycin is in the treatment of various types of cancer, including skin cancers. At the molecular level, bleomycin works by binding to DNA, causing breaks in the DNA strands, which leads to cell death. It is classified as an antineoplastic antibiotic, which means it is used to stop the growth of cancer cells.

Investigated diseases

Cutaneous Malignancies – These are cancers that occur on the skin, often presenting as abnormal growths or lesions. They can vary in appearance, sometimes resembling moles or sores that do not heal. Over time, these malignancies may grow in size and can potentially invade deeper layers of the skin or spread to other parts of the body. Common types include basal cell carcinoma, squamous cell carcinoma, and melanoma. The progression of these cancers can differ significantly, with some growing slowly and others more aggressively. Early detection and monitoring are crucial to managing their development.