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Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma

Phase 2
3 Years
18 Years
Open (Enrolling)
Diffuse Intrinsic Brainstem Gliomas

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Trial Information

Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma

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

Specific Purposes

1. To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of

2. To determine the overall survival time of the patients with diffuse intrinsic
astrocytic tumors of the cerebral trunk treated with combined radiotherapy and

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Volume

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Sidnei Epelman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Casa de Sa├║de Santa Marcelina


Brazil: Ethics Committee

Study ID:




Start Date:

December 2010

Completion Date:

December 2012

Related Keywords:

  • Diffuse Intrinsic Brainstem Gliomas
  • brainstem gliomas
  • pediatric patients
  • Glioma