Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nimotuzumab

Antineoplastic Agents, Immunological

The study consists of a single treatment group, which will receive the first-line therapy for the disease. The therapy is the standard radiotherapy and a dose of the investigational product (nimotuzumab) at 150 mg/m2.

Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.

Radiotherapy

The patients will receive the induction therapy for 12 weeks. If the patient reaches a complete, partial response (CR, PR) to the treatment or is at least evaluated as stable disease (SD) on week 12, the consolidation therapy should be initiated. The consolidation therapy will consist of the nimotuzumab administration, every 2 weeks.

Sidnei Epelman

Vicente Odone Filho

Algemir L Brunetto

Claudia T Oliveira

The study consists in only one treatment group, which will receive the first-line therapy for the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product (nimotuzumab)

General Purpose

1. To determine the therapeutic efficacy of the treatment with nimotuzumab in combination with radiotherapy in pediatric patients with diffuse intrinsic astrocytic of the brainstem glioma

Specific Purposes

1. To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of treatment.
2. To determine the overall survival time of the patients with diffuse intrinsic astrocytic tumors of the cerebral trunk treated with combined radiotherapy and nimotuzumab.
3. To determine the antitumoral objective response of the patients treated with combined radiotherapy and nimotuzumab.
4. To determine the duration time of the response in the cases of objective response reached (CR or PR) or disease stabilization.
5. To assess the toxicity of the combination AcM h-R3-nimotuzumab and radiotherapy in the patients enrolled in the clinical study.

Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma

A Magnetic Resonance Imaging (MRI) will be used for measuring the tumor volume and it will be performed before the enrollment in the clinical study and every 12 weeks. The patient follow-up will be performed for 2 years after his/her inclusion in the investigation. The final evaluation will be performed 2 years after the inclusion of the last patient.

The main response variable will be the progression-free survival by 6 months.

Centro de Immunologia Molecular, Cuba

Eurofarma Laboratorios S.A.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma	NCT01145170	Diffuse Intrins...	Radiotherapy Nimotuzumab	3 Years - 18 Years	Eurofarma Laboratorios S.A.
Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma	NCT01145170	Diffuse Intrins...	Radiotherapy Nimotuzumab	3 Years - 18 Years	Eurofarma Laboratorios S.A.
Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma	NCT01145170	Diffuse Intrins...	Radiotherapy Nimotuzumab	3 Years - 18 Years	Eurofarma Laboratorios S.A.

Spots Global Cancer Trial Database for diffuse intrinsic brainstem gliomas