Diffuse Instrinsic Ponitine Glioma Clinical Trial
Official title:
Phase III Study on the Effectiveness of OSAG 101 (Theraloc®)in Newly Diagnosed Intrinsic Pontine Gliomas of Children and Adolescents
| Verified date | March 2013 |
| Source | Oncoscience AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Observational |
Determination of efficiency of nimotuzumab in children with diffuse intrinsic pontine glioma.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | January 2012 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 20 Years |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Bonn, Children`s Medical Hospital | Bonn |
| Lead Sponsor | Collaborator |
|---|---|
| Oncoscience AG | Burdenko Neurosurgical Institute, Children`s Medical Hospital, University of Bonn, Germany, Children`s Medical Hospital, University of Homburg/Saar, Homburg/Saar, Germany, Children`s Medical Hospital, University of Leipzig, Leipzig, Germany, Children`s Medical Hospital, University of Muenster, Muenster, Germany, CRM Biometrics GmbH, Dept. of Statistics, University of Dortmund, Germany, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Hannover Medical School, Heinrich-Heine University, Duesseldorf, Istituto Nazinonale Tumori, Div. of Paediatric Oncology,Milano, Italy, University of Wuerzburg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the progression-free survival (PFS) of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy | week 12, 24, 36 | ||
| Secondary | 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 | week 12, 24, 36 |