High grade glial tumors
Conditions
Interventions
Sudy group (Nimotuzumab). 200 mg of monoclonal antibody Nimotuzumab (bulb of 50mg/10 mL) by intravenous route (antecubital vein), diluted in 250 mL of saline solution 0.9% (290 mL total volume), in 30
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with tumors glial with high-grade malignancy confirmed by pathology techniques, at the time of the inclusion in the trial, are candidates for treatment oncoespecifico or patients with the same diagnosis found in relapse, confirmed by pathology or Imaging. 2.Patients with age = 18 years of either sex. 3.General State of health according to Karnofsky index = 50%. 4.Laboratory parameters within the limits normal defined as: Hematopoietic: Hemoglobin = 9 g/l, total leukocytes = 3 x 109 cells/L, platelets = 100 x 109/l. Hepaticos: TGP/TGO and alkaline phosphatase up to 2.5 times upper limit of normal. 5.Patients expressed by voluntariness to participate in the study and informed consent signature. 6.Female patients in childbearing age who possess a negative pregnancy test and/or use effective contraception(intrauterine devices,hormonal contraceptives, tubal ligation or barrier method)in the case of male (vasectomy, condom use) prior to its inclusion and/or during your participation in the study.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or breastfeeding. 2.A second concomitant tumour patients. 3.Presence of decompensated associated chronic disease (heart disease, diabetes, hypertension). 4.A history of hypersensitivity to recombinant proteins. 5.Acute and severe allergic states. 6.Febrile states. 7.Acute septic processes. 8.Treatment with nimotuzumab 6 months prior to the inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events or deaths with causal relationship with the product under study(number of serious adverse events or deaths).Measuring time:24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of any adverse event(AE)(yes/no).Measuring time:24 months Description of the AE (name of each event occurring).Measuring time:24 months Duration of the adverse event(minutes,hours,days).Measuring time:24 months Intensity of the AE(Grade 1:mild,Grade 2:moderate,Grade 3:severe,Grade 4:life-threatening or disabling AE,Grade 5: death).Measuring time:24 months Severity of the AE(serious, not serious).Measuring time:24 months Result of the AE(death,risk of death,hospitalization/prolongation of hospitalization,persistent or significant, disability congenital anomaly / birth defect.Measuring time:24 months Causality relationship(1.Very likely/Safe/Definitive,2.Likely,3.Possible,4.Unlikely,5.Not related,6.Unknown).Measuring time:24 months Overall survival time(days).Measuring time:from the date of inclusion of each patient up to the date of death or the last date that has news of the patient. Progression-free survival(days).Measuring time:from the date of inclusion of each patient until the date of determination of the progression, death or last date that has news of the patient. Clinic response(complete response (CR),partial response (PR), stable disease (SD)and disease progression (DP).Measuring time:the 12 weeks of treatment and every 3 months | — |
Countries
Cuba
Contacts
Public ContactPatricia Piedra Sierra
Center of Molecular Immunology, CIMAB S.A
Outcome results
None listed