Ulcerated cutaneous metastases from solid tumor cancers is a particularly difficult problem with painful skin ulceration, maladorous discharge and bleeding. The intention of this study is to investigate the best palliative treatment to this group of patients. Electrochemotherapy (enhanced local uptake of bleomycin by the use of electric pulses) has proven efficient. We wish to compare electrochemotherapy with radiotherapy in the palliative setting for this patient group. MedDRA version: 9.1 Lev
Conditions
Interventions
Trade Name: Bleomycin
Product Name: Bleomycin
Pharmaceutical Form: Powder for infusion*
Current Sponsor code: AA0906
Other descriptive name: Bleomycin sulphate
Concentration unit: IU international uni
Sponsors
Department of Oncology, University Hospital Herlev
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 18 years 2) Histological proven cancer 3) Progressive and/or metastatic disease 4) One or more ulcerated cutaneous lessions 5) Patient need for palliative tretment for the cutaneous lession(s) 6) Target lession = 1 cm and = 5 cm, max 5 target lessions 7) The cutaneous lession(s) must be stationary or progressive if the patient at the same time is treated with chemotherapy. 8) WHO performancestatus = 2 9) Life expectancy =3 months 10) Platelets = 50 mia/l, pp = 40, APTT in normal area. Medical correction is alloved. 11) Sexually active men and women in the reproductive age must use safe anticonception during and up to 6 months after treatment. 12) Written informed consent must be obtained according to the local Ethics Commitee requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Previous electrochemotherapy or radiotherapy of the target area 2) Acute lunginfection 3) Previous bleomycin treatment exceeding 200.000 Units/m2 4) Known hypersensitivity to any of the components of the treatment 5) Known hypersensitivity to any of the components used in the planned anaesthesia 6) Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood. 7) Treatment with granulocyt colony stimulating factor (G-CSF) or other cytokines. 8) If creatinin is over 150 mikromolær, glomerular filtration rate must be investigated by Crom-EDTA-clearance. If Crom-EDTA-clearance < 48 ml/min the patient can not be offered treatment in the protocol. 9) Lungdiffusion kapacity (DLCO test) under the normal area. DLCO test is carried out if clinical or anamnestic suspicion of reduced lungkapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response to therapy;Secondary Objective: Safety and toxicity of the treatment. Quality of life. Patient time spend in hospital and transport Health economy. ;Primary end point(s): Response rate Safety and toxicity of the treatment | — |
Countries
Denmark
Outcome results
None listed