Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma (POLARIS)
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)
Diffuse Intrinsic Brainstem Gliomas
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma|
- Tumor Volume [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||March 2011|
|Study Completion Date:||July 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.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.
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
- To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of treatment.
- To determine the overall survival time of the patients with diffuse intrinsic astrocytic tumors of the cerebral trunk treated with combined radiotherapy and nimotuzumab.
- To determine the antitumoral objective response of the patients treated with combined radiotherapy and nimotuzumab.
- To determine the duration time of the response in the cases of objective response reached (CR or PR) or disease stabilization.
- To assess the toxicity of the combination AcM h-R3-nimotuzumab and radiotherapy in the patients enrolled in the clinical study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145170
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, RS, Brazil|
|Casa de Saúde Santa Marcelina|
|São Paulo, SP, Brazil|
|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, SP, Brazil|
|Hospital Amaral Carvalho|
|Jau, São Paulo, Brazil|
|Hospital Juan Manuel Márquez|
|Principal Investigator:||Sidnei Epelman||Casa de Saúde Santa Marcelina|
|Principal Investigator:||Vicente Odone Filho||Hospital das Clínicas da Faculda de Medicina da USP|
|Principal Investigator:||Algemir L Brunetto||Hospital de Clínicas de Porto Alegre|
|Principal Investigator:||Claudia T Oliveira||Hospital Amaral Carvalho|