Locally advanced head and neck epithelial tumors
Conditions
Interventions
Experimental group: RadioChemotherapy + Anti-EGFR mAb Nimotuzumab at 200 mg intravenously. The Nimotuzumab will have an induction phase, once a week for 8 weeks during radio-chemo and, a maintenance p
Antibodies, Monoclonal, Humanized
Chemoradiotherapy, Adjuvant
Antineoplastic Agents
Antibodies, Monoclonal
Administration, Intravenous
Nimotuzumab
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with epithelial tumors of the head and neck, confirmed by histopathology. 2.Evaluated in stages III or IV (advanced locoregional disease, non-operable). 3. That they have not previously received any oncoespecific treatment for the C and C lesion and that they are taxed on radiochemotherapy at the time of inclusion. 4. Patients with measurable lesions, defined as those that can be accurately measured in at least one dimension (refers to the largest diameter) and have a diameter =20 mm using conventional techniques (PET, CT, NMR, Rx) Or =10 mm using spiral CT. 5. Age =18 years. 6. Overall state according to ECOG ?2 (Karnofsky greater than 60%). 7. Life expectancy ?6 months. 8. Patients who have normal functioning of organs and bone marrow defined by the following parameters: • Leukocytes =3000/ L • Absolute neutrophil count = to 1500/L • Platelet count = 100,000/L • Total bilirubin: Within normal limits • TGP and TGO =2.5 times the institutional upper normal limit • Creatinine: Within normal limits 9. Female patients of childbearing potential should have a negative pregnancy test and should use appropriate contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation. 10. Patients who have signed informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Patients of childbearing potential who are not using an adequate method of contraception. 3. Patients who are receiving another drug under investigation. 4. Patients with a history of allergy to compounds of chemical or biological composition similar to nimotuzumab. 5. Patients treated with MAB egor / 3. 6. Patients unable to sign informed consent due to psychiatric problems or other medical problems. 7. Patients with uncontrolled intercurrent diseases including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illness. 8. Patients with previous neoplasias. May include those patients who have received adequate treatment for carcinomas of the skin or carcinoma in situ of the uterus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of Epidermal Growth Factor Receptor-EGFR-specific T cells (The method is based on the ELISPOT test. The technique measures secretion of cytokines related to the activation of cytotoxic T lymphocytes following stimulation of peripheral blood mononuclear cells with peptides derived from the antigen). Measurement time: 12 months. Overall survival (Time from recruitment until death from any cause). Measurement time: 3, 6, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment Objective response (measured by RECIST criteria according to Complete Response, Partial Response, Stable Disease, Progression). Measurement time: at baseline, 3, 6, 9 and 12 months. Related to Safety Adverse Events-AE (Type of AE (AE description), Intensity of AE (Light, Moderate, Severe, Very Severe, Event related Death), Causality relationship (Very likely, Probable, Possible, Unlikely, Uncontrolled, Unclassifiable), Applied Treatment (None, Medication, Surgical Procedure, Transfusion, Other), Event Result (Recovered, Continued, Unknown, Death due to event)). Measurement time: at baseline, 3, 6, 9 and 12 months. | — |
Countries
Cuba
Contacts
Public ContactZaima Mazorra Herrera
Center of Molecular Immunology
Outcome results
None listed