Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

NCT01145170 | Completed Phase 2 DMC

• 1 other identifier: EF090
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 5

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)

Conditions

Diffuse Intrinsic Brainstem Gliomas

Keywords

brainstem gliomas; pediatric patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Radiation: Radiotherapy; Biological: Nimotuzumab

Interventions

Radiotherapy RADIATION

Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.

Nimotuzumab

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.

Nimotuzumab

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Patients eligible for radiotherapy with Cobalt60. The patients should not have received a previous specific oncological treatment.
• Aged \> 3 years old \< 18 years old
• 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).
• Female patients with childbearing potential should present a negative pregnancy test and adopt effective birth control methods, in case they are sexually active.
• Male patients who can father a child should adopt effective birth control methods, in case they are sexually active.
• Life expectancy \> 12 weeks
• Health general status, according to Karnofsky Index \> 40% (Karnofsky Index for patients \> 16 years old), Lansky \> 40% (for patients \< 16 years old)
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead
• Centro de Immunologia Molecular, Cuba: collaborator

Study Sites (5)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Location

Casa de Saúde Santa Marcelina

São Paulo, São Paulo, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

Hospital Juan Manuel Márquez

Havana, Cuba

Location

MeSH Terms

Interventions

Radiotherapy; nimotuzumab

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 27, 2015

Record last verified: 2012-01

Locations

BR (4); CU (1)