subcutaneous or cutaneous metastases from any primary cancer, which are recurrent, progressive, inoperable and which have proven refractory to the conventional therapies of surgery and/or chemotherapy and/or radiotherapy
Conditions
Interventions
Trade Name: Bleomycin sulphate powder for injection
Pharmaceutical Form:
Trade Name: cisplatin sterile concentrate
Pharmaceutical Form:
Sponsors
Institut Gustav Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria for inclusion in the study: • Histologically verified cancer of any histological type. • Progressive and/or metastatic disease. • Patients must have been offered standard treatments according to the policies in the country of residence. Electrochemotherapy can be considered either in case of progression after standard treatments or in case the patient has not wished to receive such standard treatment. • Measurable cutaneous or subcutaneous tumor nodules. • Age at least 18 years. • Performance status ( Karnowsky ? 70 eq. to WHO ? 2). • Life expectancy at least 3 months. • Treatment free interval of at least 2 weeks after previously applied therapy. • Patients must be mentally capable of understanding the information given. • Patients must give informed consent . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Criteria for exclusion from the study: • Pregnancy or lactation. • Allergy to respectively cisplatin or bleomycin. Currently on systemic chemotherapy Life expectancy < 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Electrochemotherapy is a well-characterised process by which cancer cells can be made more permeable to allow anti-cancer drugs to enter the cells more easily. A large number of preclinical and clinical phase I and I/II studies have demonstrated the efficiency, safety and consistent reproducibility of electrochemotherapy. These studies have included patients with malignant melanoma, head and neck squamous cell carcinomas, basal cell carcinomas and adenocarcinoma nodules. Case reports describing the electrochemotherapy treatment of other primary cancers have also been reported. However, the widespread use of this promising approach for the treatment of solid tumours has been hampered by the lack of defined Standard Operating Procedures (SOPs). The objective of this study is to validate the clinical use of electrochemotherapy and to establish standard operating procedures suitable for their rapid and widespread use in Ireland and throughout Europe.;Secondary Objective: ;Primary end point(s): The primary end point of the trial is the development of a standard operating procedure for electrochemotherapy, whereby if the the parameters under investigation, namely electrode type, pulse length, drug type and route of administration show that one set of parameters produce an optimal means of delivering electrochemotherapy, that this should be adopted as the standard electrochemotherapy protocol for treatment of the types of metastatic cancers being treated in the trial. | — |
Countries
Ireland
Outcome results
None listed