- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00561691
Nimotuzumab in Children With Intrinsic Pontine Glioma
Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bonn, Germany, 53113
- University Bonn, Children's Medical Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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%
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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week 12, 24, 36
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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week 12, 24, 36
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Udo Bode, Prof. MD, University Bonn
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSAG101-BSC05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diffuse Instrinsic Ponitine Glioma
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University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS); The Chad-Tough... and other collaboratorsRecruitingDiffuse Intrinsic Pontine Glioma | Diffuse Midline Glioma, H3 K27M-Mutant | Recurrent Diffuse Intrinsic Pontine Glioma | Recurrent Diffuse Midline Glioma, H3 K27M-Mutant | Recurrent WHO Grade III Glioma | WHO Grade III GliomaUnited States, Israel, Australia, Netherlands, Switzerland, New Zealand
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Mayo ClinicNational Cancer Institute (NCI)RecruitingMalignant Glioma | Diffuse GliomaUnited States
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Cheng-Chia (Fred) WuFocused Ultrasound FoundationActive, not recruitingDiffuse Intrinsic Pontine Glioma | Diffuse Midline Glioma, H3 K27M-Mutant | Diffuse Pontine and Thalamic GliomasUnited States
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Luca SzalontayMidatech Pharma US Inc.CompletedDiffuse Intrinsic Pontine Glioma | Diffuse Midline Glioma | Diffuse Pontine and Thalamic GliomasUnited States
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National Cancer Institute (NCI)RecruitingRecurrent Malignant Glioma | Recurrent Medulloblastoma | Refractory Malignant Glioma | Refractory Medulloblastoma | Recurrent Diffuse Intrinsic Pontine Glioma | Recurrent Primary Central Nervous System Neoplasm | Refractory Primary Central Nervous System Neoplasm | Refractory Diffuse Intrinsic Pontine...United States, Canada
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