Effectiveness and Safety of Nimotuzumab for the treatment of patients with glioma tumors

Phase 4

• Conditions: High grade glioma tumors

• Registration Number: RPCEC00000087
• Lead Sponsor: Center of Molecular Immunology(CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified