Study to evaluate electrochemotherapy for palliative treatment in patients with head and neck cancer

Conditions: head and neck squamous cell carcinoma
MedDRA version: 16.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 16.1Level: HLGTClassification code 10019190Term: Head and neck therapeutic proceduresSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 16.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002647-29-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Patients of both sexes and equal to or more than 18 years old
2) Patients with one or more cutaneous or subcutaneous local or locoregional tumors as relapse or progression of squamous cell carcinoma of head and neck
3) Patients with a tumor that does not invade the wall of the artery carotid with risk of rupture
4) Patients whose target lesion is resistant to palliative chemotherapy and which cannot be applied palliative local treatments such as radiotherapy, surgery of scarce mutilation or first-line systemic chemotherapy
5) Patients with a expectation of life of 2-3 months
6) Patients with a degree of activity of the ECOG scale of 2 or less
7) Patients who, properly informed, consent in writing to participate in the study and submit to the tests and procedures required by the study
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Pregnancy or lactation during the study period
2) Patients with allergy to Bleomycin
3) Patients who have received the maximum dose of Bleomycin (400 mgm2)
4) Patients with previous pulmonary fibrosis or hemolytic uremic syndrome
5) Use of drugs contraindicated in the study procedure
6) Contraindication for the use of any of the drugs /products of the study
7) Hypersensitivity to any components of the anesthesia used during the procedure
8) Patients with creatinine> 1.5 values mgdL
9) Patients with severe coagulopathy prior at the entry of the study
10) Patients enrolled in other clinical trials at the same time