We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma (POLARIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01145170
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : July 27, 2015
Centro de Immunologia Molecular, Cuba
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

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)

Condition or disease Intervention/treatment Phase
Diffuse Intrinsic Brainstem Gliomas Radiation: Radiotherapy Biological: Nimotuzumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma
Study Start Date : March 2011
Primary Completion Date : June 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nimotuzumab
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.
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.

Primary Outcome Measures :
  1. Tumor Volume [ Time Frame: 6 months ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Pediatric patients with diffuse intrinsic brainstem gliomas, documented by standard imaging techniques (MRI). Note: Tumor biopsy and histological confirmation are not required in this study.
  2. Patients eligible for radiotherapy with Cobalt60. The patients should not have received a previous specific oncological treatment.
  3. Aged > 3 years old < 18 years old
  4. Patients with measurable lesions, defined as those that can be accurately measured in at least 2 dimensions (the 2 largest perpendicular diameters), using standard techniques (MRI).
  5. Female patients with childbearing potential should present a negative pregnancy test and adopt effective birth control methods, in case they are sexually active.
  6. Male patients who can father a child should adopt effective birth control methods, in case they are sexually active.
  7. Life expectancy > 12 weeks
  8. Health general status, according to Karnofsky Index > 40% (Karnofsky Index for patients > 16 years old), Lansky > 40% (for patients < 16 years old)
  9. Laboratory parameters within the normal limits, defined as: Hematopoietic: Hemoglobin > 10 g/L, Total Leukocytes > 2 x 109 cells/L, Platelets > 100 x 109/L; Hepatic: Liver functioning within the normal limits and without hepatic diseases demonstrated by ALT, AST < 2.5 x above the reference value and Total Bilirubin < 1.5 x above the reference value; Renal function: Serum Creatinine < 1.5 x above the reference value.
  10. The parents or legal guardians should express, voluntarily, in writing, that the patient will be enrolled in the study upon signature of the informed consent form. At the investigator's discretion, where applicable, the consent will be obtained from the minor.

Exclusion Criteria:

  1. Low-grade brainstem glioma (e.g., focal, cervicomedullary, tectal brainstem glioma).
  2. Patients previously treated with some AcM.
  3. Patients previously treated with some antineoplastic therapy, including chemotherapy, immunotherapy or radiotherapy.
  4. Concurrent treatment with some antineoplastic therapy not conceived in the study protocol.
  5. Breastfeeding or pregnant patients.
  6. Patients that, at the time of enrollment, have some related chronic disease under decompensation (e.g., cardiopathy, diabetes, hypertension).
  7. Patients who have history of hypersensitivity to this or another similar product.
  8. Fever, severe septic processes and/or severe or acute allergy.
  9. Patients who are participating in another clinical study with therapeutic purposes for their disease based on the time of the study enrollment.
  10. Presence of a second tumor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Havana, Cuba
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Centro de Immunologia Molecular, Cuba
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

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01145170     History of Changes
Other Study ID Numbers: EF090
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: January 2012

Keywords provided by Eurofarma Laboratorios S.A.:
brainstem gliomas
pediatric patients

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue