High grade glioma tumors
Conditions
Interventions
Nimotuzumab: 200 mg intravenous (antecubital vein) in a volume of 250 ml (complete with saline) infusion for one hour. Induction Phase: 200mg (once per week) for 6 weeks. If the patient is newly diagn
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with glials tumors grade III or IV confirmed by pathology techniques,which at the time of inclusión are candidates for onco-specific treatment or patients with the same diagnosis who are relapsed. 2.Age = 18 years of both sexes. 3.General health status according to Karnofsky index = 50. 4.Laboratory parameters within normal limits defined as:Hematopoietic:Hemoglobin = 9 g/L,total leukocytes count = 3 x 109 cells/L,platelets = 100 x 109/L Hepatic:hepatic function within 2.5 times upper limit of normal and without liver diseases demonstrated by TGP and TGO alkaline phosphatase. 5.Patients express written voluntary entry into the study by signing the document informed consent. 6.Patients of childbearing age should have a negative pregnancy test and used effective methods of contraception such as IUDs,hormonal contraceptives, barrier method or tubal ligation.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation. 2.Patients with a concomitant second tumor. 3.Submit a chronic disease associated in decompensated phase(heart disease,diabetes,hypertension). 4.History of hypersensitivity to other similar product. 5.Severe acute allergic states. 6.Fever. 7.Severe septic processes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Survival Time (in months) from inclusion date to death or last news. Measurement time: From the inclusion date to the date of death or last news date. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AE). Measuring Time: in every administration of the product. It is compound by: -Description of AE (name of AE) -Intensity of AE (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Danger to life, Grade 5: Death) -Causation of AE (very likely causality, likely Causality, possible Causality, not related, Unknown) Objective antitumor response evaluated using MacDonald criteria (Complete response, partial response, progressive disease, stable disease). Measurement Time: Prior to inclusion in the clinical trial, at week 8 and every 3 months to 24 months. Progression-free survival (PFS). Time between the start of treatment at the date of clinical progression or imaging/last scheduled visit when there is news of the patient/or date of death. Measuring Time: since the start of treatment at the last scheduled visit when there is news of the patient/or date of death. | — |
Countries
Cuba
Contacts
Public ContactGiselle Saurez Martínez
CIMAB S.A
Outcome results
None listed