Diffuse Instrinsic Ponitine GliomaNCT00561691
Nimotuzumab in Children With Intrinsic Pontine Glioma
An observational study of Diffuse Instrinsic Ponitine Glioma, run by Oncoscience AG at 1 site in Germany.
Trial summary
Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Diffuse Instrinsic Ponitine Glioma
- What is being tested?
- nimotuzumab
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Jan 2012
- 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 and adolescents
Who may be able to join
- Histology and staging of disease:
- Newly diagnosed intrinsic pontine glioma documented by MRI and measurable in at least one dimension
- Histology is not required for this study, tumour biopsy is not recommended General conditions
- Age ≥ 3 years to ≤ 20 years, both gender
- Life expectancy ≥ 4 weeks
- Performance status ECOG ≥ 3 or Karnofsky/Lansky status ≥ 40%
Show all 18Show fewer
- Adequate haematological, renal, and hepatic function Absolute leukocyte count ≥ 2.0 x 109/l Haemoglobin ≥ 10 g/dl Platelets ≥ 50 x 109/l Bilirubin total ≤ 2.5 x ULN ALT/AST ≤ 5.0 x ULN Creatinine i. S. ≤ 1.5 x ULN
- Prior/initial examinations (within 14 days prior to the start of therapy):
- Cranial MRI (estimation of index lesion)
- Clinical internal and neurological examination; body weight, height, surface, Performance status by ECOG, Karnofsky or Lansky
- Blood cell count, blood gas analysis; serum analysis for electrolytes (Na, K, Ca, Mg), chloride, phosphate, creatinine, BUN, AST, ALT, bilirubin, GGT, LDH, lipase, total protein, CRP, blood sugar; coagulation test (Quick, PTT, TT); urinalysis
- EKG, echocardiography in case of positive cardiac history
- Pregnancy test in females of childbearing age Other criteria
- Planned day of first antibody application within 14 days after MRI
- Written and signed informed consent from patient and/or parents or legal guardian(s)(s) after being informed
- Negative pregnancy test in females of childbearing age
- Treatment in a study centre
- Availability of the patient during the study treatment and the ability to comply with the study plan
Who cannot join
- Pontine glioma as secondary malignancy
- Low grade brain stem glioma (i.e. focal, cervicomedullar, tectal brain stem glioma)
- Other severe underlying disease or pre-existing serious conditions which bear the risk of an inadequate study treatment (e.g. severe mental retardation, severe statomotoric retardation, severe cerebral palsy, congenital syndromes)
- Prior antineoplastic therapy, inclusively chemotherapy, immunotherapy, radiotherapy
- Prior administration of a recombinant human or mural antibody or known hypersensitivity to antibodies
- Simultaneous antineoplastic therapy other than the study treatment
- Participation in another therapeutic study or experimental treatment involving the underlying cancer disease
- Pregnancy, lactating mother and inadequate contraception in females and males of childbearing age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents
Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.
Read the detailed description
Due to the poor prognosis of diffuse intrinsic pontine gliomas, the limited therapy options, the relevant portion of EGFR expression and the unexpected good response to the therapy with OSAG 101 in the phase II study, a phase III study was planned in newly diagnosed diffuse intrinsic pontine gliomas in children and adolescents. A phase II study in patients of recurrence/resistance high grade glioma in childhood or adolescence showed that, in particular, a part of the intrinsic pontine glioma response to the monotherapy with OSAG 101 resulting in a reduction in the size of the tumour or stabilisation in the growth of the tumour. Together with clinical improvement, stabilisation lasted markedly over 6 months in two thirds of the patients. The current phase III study was scheduled to provide evidence of the effectiveness in the case of newly diagnosed intrinsic pontine glioma. In this study, OSAG 101 will be given concomitantly to the only standard therapy for this kind of tumour, i.e. the fractionated radiotherapy, to show effectiveness in the primary endpoint of median progression-free survival, the secondary endpoint of median overall survival and the side effect profile.
Evidence from the median progression-free survival and the side effect profile of this combination met the expected results and one may consider that combination therapy of this therapeutic approach with other immunotherapeutic or antiangiogenic approaches and/or mild chemotherapy could lead to a better prognosis and quality of life for these patients.
- Conditions
- Diffuse Instrinsic Ponitine Glioma
- Being tested
- nimotuzumab
- Keywords
- diffuse instrinsic ponitine glioma, brainstem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
Also called Theraloc
monoclonal antibody
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy
Measured: week 12, 24, 36
Secondary outcomes (1)
To determine the objective response rate (R=CR+PR+SD/Nr) according to RECIST To determine the duration of response and the overall survival To assess adverse events and the toxicity profile according to CTCAE version 3.0
Measured: week 12, 24, 36
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 startApr 2006
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Instrinsic Ponitine 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
- 41 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, Dept. of Statistics, University of Dortmund, Germany, CRM Biometrics GmbH, Heinrich-Heine University, Duesseldorf, 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 Leipzig, Leipzig, Germany, Children's Medical Hospital, University of Muenster, Muenster, Germany, Burdenko Neurosurgery Institute, Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy
- Responsible party
- Sponsor
- Investigators
- Udo Bode, Prof. MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561691
- Sponsor's protocol ID
- OSAG101-BSC05
- Status last verified
- Mar 2013
- First submitted
- 20 Nov 2007
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents
- ClinicalTrials.gov ID
- NCT00561691
- Acronym / sponsor ID
- OSAG101-BSC05
- Conditions
- Diffuse Instrinsic Ponitine Glioma
- Keywords
- diffuse instrinsic ponitine glioma, brainstem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oncoscience AGIndustry (pharma, biotech, devices)
- Collaborators
- Children's Medical Hospital, University of Bonn, Germany, University of Wuerzburg, Dept. of Statistics, University of Dortmund, Germany, CRM Biometrics GmbH, Heinrich-Heine University, Duesseldorf, 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 Leipzig, Leipzig, Germany, Children's Medical Hospital, University of Muenster, Muenster, Germany, Burdenko Neurosurgery Institute, Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy
- Study start
- Apr 2006
- Study completion
- Jan 2012 (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 diffuse intrinsic pontine glioma.
Detailed description
Due to the poor prognosis of diffuse intrinsic pontine gliomas, the limited therapy options, the relevant portion of EGFR expression and the unexpected good response to the therapy with OSAG 101 in the phase II study, a phase III study was planned in newly diagnosed diffuse intrinsic pontine gliomas in children and adolescents. A phase II study in patients of recurrence/resistance high grade glioma in childhood or adolescence showed that, in particular, a part of the intrinsic pontine glioma response to the monotherapy with OSAG 101 resulting in a reduction in the size of the tumour or stabilisation in the growth of the tumour. Together with clinical improvement, stabilisation lasted markedly over 6 months in two thirds of the patients. The current phase III study was scheduled to provide evidence of the effectiveness in the case of newly diagnosed intrinsic pontine glioma. In this study, OSAG 101 will be given concomitantly to the only standard therapy for this kind of tumour, i.e. the fractionated radiotherapy, to show effectiveness in the primary endpoint of median progression-free survival, the secondary endpoint of median overall survival and the side effect profile.
Evidence from the median progression-free survival and the side effect profile of this combination met the expected results and one may consider that combination therapy of this therapeutic approach with other immunotherapeutic or antiangiogenic approaches and/or mild chemotherapy could lead to a better prognosis and quality of life for these patients.
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 and adolescents
Key inclusion criteria (18 listed)
- Newly diagnosed intrinsic pontine glioma documented by MRI and measurable in at least one dimension
- Histology is not required for this study, tumour biopsy is not recommended General conditions
- Age ≥ 3 years to ≤ 20 years, both gender
- Life expectancy ≥ 4 weeks
- Performance status ECOG ≥ 3 or Karnofsky/Lansky status ≥ 40%
Key exclusion criteria (8 listed)
- Pontine glioma as secondary malignancy
- Low grade brain stem glioma (i.e. focal, cervicomedullar, tectal brain stem glioma)
- Other severe underlying disease or pre-existing serious conditions which bear the risk of an inadequate study treatment (e.g. severe mental retardation, severe statomotoric retardation, severe cerebral palsy, congenital syndromes)
- Prior antineoplastic therapy, inclusively chemotherapy, immunotherapy, radiotherapy
- Prior administration of a recombinant human or mural antibody or known hypersensitivity to antibodies
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 |
|---|---|---|
| nimotuzumabAlso: Theralocmonoclonal antibody | Drug | – |
Primary outcome
To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy
Time frame: week 12, 24, 36
1 secondary outcome
To determine the objective response rate (R=CR+PR+SD/Nr) according to RECIST To determine the duration of response and the overall survival To assess adverse events and the toxicity profile according to CTCAE version 3.0
Time frame: week 12, 24, 36
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 29 Mar 2013.
- Related InfoLink provided by the sponsor.
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 Diffuse Instrinsic Ponitine 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 18 inclusion and 8 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 29 Mar 2013. 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?
To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy (time frame: week 12, 24, 36). 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 29 Mar 2013.