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Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

NCT01145170 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-07-27

No results posted yet for this study

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)

Conditions

  • Diffuse Intrinsic Brainstem Gliomas

Interventions

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.

Sponsors & Collaborators

  • Centro de Immunologia Molecular, Cuba

    collaborator INDUSTRY

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Sidnei Epelman · Casa de Saúde santa Marcelina

  • Vicente Odone Filho · Hospital das Clínicas da Faculda de Medicina da USP

  • Algemir L Brunetto · Hospital de Clínicas de Porto Alegre

  • Claudia T Oliveira · Hospital Amaral Carvalho

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Brazil
  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01145170 on ClinicalTrials.gov