The Effect of Reduced Bleomycin in Electrochemotherapy Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Bleomycin: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• To evaluate the clinical overall response rate of electrochemotherapy treatment of cutaneous malignancies after three months — The tumors will be meassured before electrochemotherapy (baseline) and three months after electrochemotherapy treatment.
  The response to treatment will be evaluated according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Response rate will be defined as the number of responding tumours relative to the number of treated tumours (Intention to treat analysis, ITT), evaluated 3 months after treatment. The response will be evaluated by clinical examination with ruler measurements (in mm) and photographical documentation using rulers for scale.

Trial sites (2)