Phase III study on the effectiveness of OSAG 101 Theraloc in newly diagnosed intrinsic pontine gliomas of children and adolescents - ND

Conditions: newly diagnosed intrinsic pontine gliomas of children and adolescents
MedDRA version: 6.1Level: PTClassification code 10018338

Registration Number: EUCTR2005-003100-11-IT

Lead Sponsor: ONCOSCIENCE AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Newly diagnosed intrinsic pontine glioma documented in MRI and measurable in at least one dimension Age o 3 3 years to o 20 years, both gender Life expectancy o 4 weeks Performance status ECOG o 3 or Karnofsky/Lansky status o 40 Adequate hematological, renal, and hepatic function
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 Simultaneously other antineoplastic therapy 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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the progression-free survival PFS of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy in newly diagnosed intrinsic pontine gliomas;Secondary Objective: To determine the progression-free survival PFS of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy in newly diagnosed intrinsic pontine gliomas;Primary end point(s): Probability of a patient to survive progression-free 6 months after diagnosis

Secondary Outcome Measures