head and neck squamous cell carcinoma MedDRA version: 16.1 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: HLGT Classification code 10019190 Term: Head and neck therapeutic procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 16.1 Level: PT Classification code 10067821 Term: Head and neck cance
Conditions
Interventions
Trade Name: Bleomicina Mylan
Product Name: bleomycin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056-06-7
Concentration unit: mg/m2 milligram(s)
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Palliation of symptoms in patients who have one or more tumors cutaneous or subcutaneous as relapse or progression of carcinoma of head and neck palliative chemotherapy-resistant and those no other effective local treatments can be offered.;Secondary Objective: 1 Evaluation of tumor response 2. Progression-free survival 3. Overall survival 4 Tolerance and toxicity of the procedure 5. Exploratory analysis of possible factors involved in response and clinical progression;Primary end point(s): Assessment of changes in symptoms using the test of quality of life of Edmonton at 6 weeks after the procedure with respect to the baseline.;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Response rate objective: incidence of complete response or partial response or tumor stabilization according to RECIST 1.1 criteria at 6 and 12 weeks of treatment. 2. Time elapsed since the date of the inclusion until progression of disease according to RECIST 1.1 criteria 3. Time elapsed since the date of the inclusion until the date of death. 4 Incidence of systemic and local events related to the study procedure 5 Incidence of events adverse serious procedure in study-related 6. Exploratory analysis of possible factors involved in response and clinical progression;Timepoint(s) of evaluation of this end point: 6 weeks, 12 weeks, at the end of study | — |
Countries
Spain
Contacts
Public ContactJudit Pich
Clinical Trials Unit (CTU)
Outcome results
None listed