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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2013 |
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Main ID: |
NCT00561691 |
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Date of registration:
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20/11/2007 |
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Primary sponsor: |
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Public title:
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Nimotuzumab in Children With Intrinsic Pontine Glioma
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Scientific title:
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Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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41 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00561691 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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Germany
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Contacts
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Name:
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Udo Bode, Prof. MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Bonn |
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Key inclusion & exclusion criteria
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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
Age minimum:
3 Years
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diffuse Instrinsic Ponitine Glioma
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Intervention(s)
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Drug: nimotuzumab
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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Secondary ID(s)
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OSAG101-BSC05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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