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| Name | Class |
|---|---|
| Centro de Immunologia Molecular, Cuba | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Volume | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil | |||
| Hospital Amaral Carvalho |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Nimotuzumab | Biological | 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. |
|
| Jaú |
| São Paulo |
| Brazil |
| Casa de Saúde Santa Marcelina | São Paulo | São Paulo | Brazil |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | Brazil |
| Hospital Juan Manuel Márquez | Havana | Cuba |