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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000087
• Date of registration: 18/09/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Effectiveness and Safety of Nimotuzumab for the treatment of patients with glial tumors
• Scientific title: Evaluation of the Effectiveness and Safety of Monoclonal Antibody HR3(Nimotuzumab)for the treatment of patients with glial tumors of high grade malignancy.
• Date of first enrolment: 29/09/2008
• Target sample size: Inclusion of 3 years.
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000087-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: none
Gender: Both

Health Condition(s) or Problem(s) studied

Glial Tumors of High grade of Malignancy (Glial Cell Tumors).

Intervention(s)

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 diagnosed, this treatment will be received concomitant with radiation therapy (RT). If after 15 days of surgery, is not possible to begin the RT, treatment with Nimotuzumab will begin, and the induction phase will continue until the end of RT. Radiotherapy (RT):1.8-2Gy daily, split into 5d/week (Monday-Friday). Total dose: between 50 and 60Gy for 5-6 weeks. Maintenance and consolidation phase: One time every 14 days until the patient's deterioration from the disease or toxicity not tolerated.

Primary Outcome(s)

Global Survival. Time (in months) from inclusion date to death or last date you have news. Measurement time: From the inclusion date to the date of death or last date there is news.

Secondary Outcome(s)

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.

Secondary ID(s)

IIC RD-EC0114

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable