Tumors of head and neck in advanced stages.
Conditions
Interventions
nimotuzumab, radiotherapy (RT), chemotherapy(QT) Treatment schemes: A NimoRT (RT + nimotuzumab) B NimoRT-QT (RT-QT + nimotuzumab) C Nimo-QT (QT + nimotuzumab) D Nimo (nimotuzumab) nimotuzumab: Ambulat
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patient that expresses the voluntary written into the studio with the signing of the informed consent. 2.Patient with age equal or greater than 18 years. 3.Expectation of life equal to or greater than 6 months. 4.Clinical status according to criteria of the ECOG less than or equal to 3. 5.Laboratory parameters(considering type of processing and equipment used): Hematopoietic - hemoglobin (Hb) greater than or equal to 100g/L hematocrit 0.30-0.40 in women and 0.30-0.44 in men, count of leukocytes ? 3000/?L = 3 x 109 L, CAN ? 1500/?L = 1.5 x 109 /L, platelets count greater than or equal to 100000/?L = 100 x 109 L, biochemical-liver: ALAT (TGP), ASAT (TGO), alkaline phosphatase, up to 2.5 times upper limit of normal for each clinical site; LDH and albumin normal value; Kidney: serum creatinine normal value.
Exclusion criteria
Exclusion criteria: 1.Pregnancy, postpartum or breastfeeding. 2.Chronic disease associated in stage of decompensation (example: heart disease, diabetes mellitus, arterial hypertension). 3.Brain metastasis, diagnosed by TAC, not controlled or in progression. 4.Presence of a second primary tumor, with the exception of basal carcinomasor squamous skin and carcinoma in situ treated neck. 5.Patient who is receiving another investigational medicinal product at the time of inclusion. 6.Treatment with nimotuzumab in the 6 months prior to the time of inclusion. 7.Prior knowledge of allergy or sensitivity to the nimotuzumab or any component of the formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious EA with causal relationship with nimotuzumab (definitive, very likely or probable).Measuring time:24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| .Type of adverse event(event).Measuring time:24 months .Time between the moment of administration and the appearance of the EA(hours and minutes or days).Measuring time:24 months .Duration of the EA (days or hours and minutes).Measuring time:24 months .Seriousness of the EA (serious or not serious).Measuring time:24 months .Intensity of the EA(grade 1 Mild, grade 2 Moderate , grade 3 Severe, grade 4 Life -threatening or disabling , grade 5 Death).Measuring time:24 months .Causality Relationship(unknown, not related, possible, likely, very likely, and definitive).Measuring time:24 months .Attitude followed before the appearance of the EA(none, reduction of the dosage, temporary interruption of treatment, discontinuation of treatment).Measuring time:24 months .Treatment of the EA(indicated treatment to counteract the EA).Measuring time:24 months .Result of the EA(reversible effect, irreversible effect, death or loss of the follow-up of the patient).Measuring time:24 months .Lot of the nimotuzumab (the lot number of the used bulb for each administration the lot number of the used bulb for each administration).Measuring time:24 months .Clinical laboratory examinations(normal, out of the normal range not significant and out of significant normal range).Measuring time:previous inclusion,every 28 days in case of diagrams A Nimo RT and D Nimo, and schemas B Nimo RT-QT and C Nimo-QT before each cycle of QT and at the conclusion of the QT every 28 days .Overall survival(time in days or months elapsed since the inclusion of the patient in the study until his death or date in which are recorded in the HC the latest news from the patient).Measuring time:24 months .Quality of life(from the EORTC life quality questionnaires).Measuring time:at the time of inclusion and a semi-annual frequency during the 24 months of treatment .Progression-free survival( time in days or months elapsed from the moment that gets a response in the patient until it is objectively documented progressi | — |
Countries
Cuba
Contacts
Public ContactPatricia Piedra Sierra,MD.
Center of Molecular Immunology (CIM), CIMAB SA.
Outcome results
None listed