Actively Recruiting
The Effect of Reduced Bleomycin in Electrochemotherapy Treatment
Led by Julie Gehl · Updated on 2025-01-23
55
Participants Needed
2
Research Sites
165 weeks
Total Duration
On this page
Sponsors
J
Julie Gehl
Lead Sponsor
R
Roskilde University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Reduced Bleomycin in Electrochemotherapy Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Be able to understand the participant information
- Have a biopsy-confirmed cutaneous or subcutaneous cancer of any type
- Have a life expectancy longer than 3 months
- Be able to receive other cancer treatments during the study
- May have had previous electrochemotherapy if treated tumors are different or at least 3 months have passed
- May have had radiation therapy if not in the treatment area or at least 3 months have passed since treatment in the area
- Have normal or acceptable kidney function (normal creatinine or creatinine clearance above 50 ml/min)
- Use effective contraception if sexually active
- Provide signed informed consent
You will not qualify if you...
- Be pregnant or breastfeeding (negative pregnancy test required before treatment)
- Have allergy or hypersensitivity to bleomycin
- Have an acute lung infection
- Have severely impaired lung function or other serious lung conditions
- Have any medical condition or previous treatments that make participation unsafe
- Have exceeded the maximum recommended cumulative dose of bleomycin
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Trial Site Locations
Total: 2 locations
1
Copenhagen University Hospital Herlev-Gentofte
Herlev, Denmark, 2730
Actively Recruiting
2
Zealand University Hospital
Roskilde, Denmark, 4000
Actively Recruiting
Research Team
J
Julie Gehl, MD, Dr.Med.
CONTACT
M
Marie Tolstrup, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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