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.
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
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
- 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
- To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of treatment.
- To determine the overall survival time of the patients with diffuse intrinsic astrocytic tumors of the cerebral trunk treated with combined radiotherapy and nimotuzumab.
- To determine the antitumoral objective response of the patients treated with combined radiotherapy and nimotuzumab.
- To determine the duration time of the response in the cases of objective response reached (CR or PR) or disease stabilization.
- To assess the toxicity of the combination AcM h-R3-nimotuzumab and radiotherapy in the patients enrolled in the clinical study.
- Conditions
- Diffuse Intrinsic Brainstem Gliomas
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiotherapy; Biological: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Jun 2010 (estimated)
- Study startMar 2011
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Intrinsic Brainstem GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro de Immunologia Molecular, Cuba
- Responsible party
- Sponsor
- Investigators
- Sidnei Epelman, Principal investigator, Casa de Saúde santa MarcelinaVicente Odone Filho, Principal investigator, Hospital das Clínicas da Faculda de Medicina da USPAlgemir L Brunetto, Principal investigator, Hospital de Clinicas de Porto AlegreClaudia T Oliveira, Principal investigator, Hospital Amaral Carvalho
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma
- ClinicalTrials.gov ID
- NCT01145170
- Acronym / sponsor ID
- POLARIS / EF090
- Conditions
- Diffuse Intrinsic Brainstem Gliomas
- Keywords
- brainstem gliomas, pediatric patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Collaborators
- Centro de Immunologia Molecular, Cuba
- Study start
- Mar 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
General Purpose
- 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
- To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of treatment.
- To determine the overall survival time of the patients with diffuse intrinsic astrocytic tumors of the cerebral trunk treated with combined radiotherapy and nimotuzumab.
- To determine the antitumoral objective response of the patients treated with combined radiotherapy and nimotuzumab.
- To determine the duration time of the response in the cases of objective response reached (CR or PR) or disease stabilization.
- To assess the toxicity of the combination AcM h-R3-nimotuzumab and radiotherapy in the patients enrolled in the clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Experimental | Radiation: Radiotherapy, Biological: NimotuzumabThe 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system. | Radiation | Nimotuzumab |
| NimotuzumabThe 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. | Biological | Nimotuzumab |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidnei Epelman principal investigator
Casa de Saúde santa Marcelina
Vicente Odone Filho principal investigator
Hospital das Clínicas da Faculda de Medicina da USP
Algemir L Brunetto principal investigator
Hospital de Clinicas de Porto Alegre
5 sites in 2 countries: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.