Spots Global Cancer Trial Database for Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma
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Trial Identification
Brief Title: Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma
Official Title: Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma
Study ID: NCT01145170
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Havana, , Cuba
Contact Details
Name: Sidnei Epelman
Affiliation: Casa de Saúde santa Marcelina
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente Odone Filho
Affiliation: Hospital das Clínicas da Faculda de Medicina da USP
Role: PRINCIPAL_INVESTIGATOR
Name: Algemir L Brunetto
Affiliation: Hospital de Clínicas de Porto Alegre
Role: PRINCIPAL_INVESTIGATOR
Name: Claudia T Oliveira
Affiliation: Hospital Amaral Carvalho
Role: PRINCIPAL_INVESTIGATOR
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