NCT01145170

Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Diffuse Intrinsic Brainstem Gliomas

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.
BIOLOGICAL	Nimotuzumab	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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2010-06-16
• Last updated: 2015-07-27

Locations

5 sites across 2 countries: Brazil, Cuba