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Diffuse Intrinsic Brainstem GliomasPhase 2POLARISNCT01145170

Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

A Phase 2 study testing Radiotherapy and Nimotuzumab in people with Diffuse Intrinsic Brainstem Gliomas, run by Eurofarma Laboratorios S.A. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Diffuse Intrinsic Brainstem Gliomas
What is being tested?
Radiotherapy and Nimotuzumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesin 2 countries
Study dates
Mar 2011to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Brazil4 sites

  • Hospital Amaral Carvalho

    Jaú, São Paulo

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Casa de Saúde Santa Marcelina

    São Paulo, São Paulo

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

    São Paulo, São Paulo

Other trials in Brazil

Cuba1 site

  • Hospital Juan Manuel Márquez

    Havana

Other trials in Cuba

About this study

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

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)

Read the 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.
Being tested
Radiotherapy, Nimotuzumab
Keywords
brainstem gliomas, pediatric patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

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

  • NimotuzumabBiological

    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.

Study groups in NCT01145170
Study groupRoleWhat they receive
NimotuzumabExperimentalThe 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.
Receives: Radiation: Radiotherapy; Biological: Nimotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01145170
Sponsor's protocol ID
EF090
Acronym
POLARIS
Status last verified
Jan 2012
First submitted
14 Jun 2010
Last updated
27 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy and Nimotuzumab in people with Diffuse Intrinsic Brainstem Gliomas, run by Eurofarma Laboratorios S.A. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil, Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Volume (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.

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