High Grade GliomaNCT00561873
Nimotuzumab in Children With HGG
An observational study of High Grade Glioma, run by Oncoscience AG at 1 site in Germany.
Trial summary
Determination of efficiency of nimotuzumab in children with high grade glioma. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- High Grade Glioma
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2004to Feb 2007
- Phase
- Observational
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children, adolescents
Who may be able to join
- Histologically confirmed diagnosis of high grade glioma (WHO III und IV) [not needed for intrinsic pontine glioma]
- Progressive patients under primary therapy or first and second radiologically confirmed recurrence(MRI not older than 2 weeks) of high grade gliomas between the age of > 3 years < 20 years
- Lack of curative standard therapy which is currently under investigation in a national GPOH-therapy optimization study
- Sufficient haematological, renal and hepatic function (CTC Grad ≤ 2)
- Disease measurable radiologicaly in at least one dimension
- Life expectancy > 4 Weeks
- Written declaration of consent of the parents/legal guardians and if possible of the child after prior information
Who cannot join
- Curative therapy with an alternative method after diagnosis of progression and during this study
- Prior administration of human or murine antibody
- Pregnancy in girls of child-bearing age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma
Determination of efficiency of nimotuzumab in children with high grade glioma.
Read the detailed description
High grade malignant gliomas are tumors grade III and IV according to WHO classification, that originate from oligodendroglia and astrocytes, where the latter are also known as anaplastic astrocytoma(WHO grade III) and glioblastoma(WHO grade IV). This also includes intrinsic pontine gliomas of adolescents, which are usually not documented histologically due to their localisation, but they have a similar clinical progress when compared to high grade malignant astrocytic tumors. Among various molecular alterations, malignant gliomas overexpress EGFR (epidermal growth factor) in nearly 50% of cases, which is particularly pronounced in glioblastoma.(Schlegel 2003) Standard therapy consists of radical surgery as extensive as medically responsible followed by radiotherapy dose of 60 Gy, which is aimed at the area with a safety margin. The long-term efficacy of additional chemotherapy has been a subject for controversy for several decades. The combination of all three treatment modalities in grade III tumors can lead to median survival times of 3-5 years in adults.
For this treatment group reports of 5 year recurrence free periods in 33-50% of cases have been reported in children and adolescents.
For glioblastoma(WHO grade IV) 5year recurrence free periods are 3% in elderly patients and 10-20% for adolescents.(Schlegel 2003) In German speaking territories chemotherapy with Cisplatin, Etoposid and Ifosfamid is used as a postoperative treatment option for adolescents and this disease.(Wolff HIT-GBM) In case of recurrence therapy choices are even more limited, thus if medically feasible the enrolment in clinical trials is an option.
In this study the aim is to use an antibody directed against the EGF-receptor to effect the proliferation of the tumor cells negatively. Pilot studies conducted in adults indicate that the median survival time for patients with malignant glioma can be prolonged by the antibody treatment.
- Conditions
- High Grade Glioma
- Keywords
- astrocytoma, glioblastoma, intrinsic pontine glioma
- Medical subject headings
- Glioma, Astrocytoma, Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate according to RECIST criteria
Measured: week 8, week 21
Secondary outcomes (1)
Progress free interval, Toxicity according to CTC criteria, Symptom control
Measured: week 8, week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJun 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncoscience AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Medical Hospital, University of Bonn, Germany, University of Wuerzburg, University of Bonn, Dept. of Statistics, University of Dortmund, Germany, CRM Biometrics GmbH, Heinrich-Heine University, Duesseldorf, University Hospital Augsburg, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany, Children's Medical Hospital, Medical School Hannover, Hannover, Germany, Children's Medical Hospital, University of Essen, Essen, Germany, Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany, University of Cologne, Universitätsklinikum Hamburg-Eppendorf, University of Regensburg
- Investigators
- Udo Bode, Prof. MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561873
- Sponsor's protocol ID
- BN001-PED04
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 21 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-II-Study of Efficacy of OSAG 101 (Theraloc®) for Adolscent Patients With Recurrent High Grade Glioma
- ClinicalTrials.gov ID
- NCT00561873
- Acronym / sponsor ID
- BN001-PED04
- Conditions
- High Grade Glioma
- Keywords
- astrocytoma, glioblastoma, intrinsic pontine glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Oncoscience AGIndustry (pharma, biotech, devices)
- Collaborators
- Children's Medical Hospital, University of Bonn, Germany, University of Wuerzburg, University of Bonn, Dept. of Statistics, University of Dortmund, Germany, CRM Biometrics GmbH, Heinrich-Heine University, Duesseldorf, University Hospital Augsburg, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Children's Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany, Children's Medical Hospital, Medical School Hannover, Hannover, Germany, Children's Medical Hospital, University of Essen, Essen, Germany, Dept. of Neuropediatrics and Muscle Disorders, University of Freiburg, Germany, University of Cologne, Universitätsklinikum Hamburg-Eppendorf, University of Regensburg
- Study start
- Jun 2004
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Nov 2007 (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.
Determination of efficiency of nimotuzumab in children with high grade glioma.
Detailed description
High grade malignant gliomas are tumors grade III and IV according to WHO classification, that originate from oligodendroglia and astrocytes, where the latter are also known as anaplastic astrocytoma(WHO grade III) and glioblastoma(WHO grade IV). This also includes intrinsic pontine gliomas of adolescents, which are usually not documented histologically due to their localisation, but they have a similar clinical progress when compared to high grade malignant astrocytic tumors. Among various molecular alterations, malignant gliomas overexpress EGFR (epidermal growth factor) in nearly 50% of cases, which is particularly pronounced in glioblastoma.(Schlegel 2003) Standard therapy consists of radical surgery as extensive as medically responsible followed by radiotherapy dose of 60 Gy, which is aimed at the area with a safety margin. The long-term efficacy of additional chemotherapy has been a subject for controversy for several decades. The combination of all three treatment modalities in grade III tumors can lead to median survival times of 3-5 years in adults.
For this treatment group reports of 5 year recurrence free periods in 33-50% of cases have been reported in children and adolescents.
For glioblastoma(WHO grade IV) 5year recurrence free periods are 3% in elderly patients and 10-20% for adolescents.(Schlegel 2003) In German speaking territories chemotherapy with Cisplatin, Etoposid and Ifosfamid is used as a postoperative treatment option for adolescents and this disease.(Wolff HIT-GBM) In case of recurrence therapy choices are even more limited, thus if medically feasible the enrolment in clinical trials is an option.
In this study the aim is to use an antibody directed against the EGF-receptor to effect the proliferation of the tumor cells negatively. Pilot studies conducted in adults indicate that the median survival time for patients with malignant glioma can be prolonged by the antibody treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children, adolescents
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of high grade glioma (WHO III und IV) [not needed for intrinsic pontine glioma]
- Progressive patients under primary therapy or first and second radiologically confirmed recurrence(MRI not older than 2 weeks) of high grade gliomas between the age of > 3 years < 20 years
- Lack of curative standard therapy which is currently under investigation in a national GPOH-therapy optimization study
- Sufficient haematological, renal and hepatic function (CTC Grad ≤ 2)
- Disease measurable radiologicaly in at least one dimension
Key exclusion criteria (3 listed)
- Curative therapy with an alternative method after diagnosis of progression and during this study
- Prior administration of human or murine antibody
- Pregnancy in girls of child-bearing age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response rate according to RECIST criteria
Time frame: week 8, week 21
1 secondary outcome
Progress free interval, Toxicity according to CTC criteria, Symptom control
Time frame: week 8, week 21
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 21 Nov 2007.
- Related InfoLink provided by the sponsor.
Related trials for High Grade Glioma
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Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
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Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
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A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Currently Only Enrolling Glioblastoma Patients at First Recurrence
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.
Udo Bode, Prof. MD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Glioma, run by Oncoscience AG at 1 site in Germany.
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 7 inclusion and 3 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 21 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Response rate according to RECIST criteria (time frame: week 8, week 21). 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 21 Nov 2007.