Phase III Study on the effectiveness of OSAG 101 (Theraloc) in newly diagnosed intrinsic pontine gliomas of children and adolescents - N.A.
- Conditions
- ewly diagnosed pontine glioma
- Registration Number
- EUCTR2005-003100-11-DE
- Lead Sponsor
- Oncoscience AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Histology and staging of disease:
•Newly diagnosed diffuse intrinsic pontine glioma documented by MRI and measurable in at least one dimension
•Histology is not required for this study as 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 %
•Sufficient hematological, renal, and hepatic function according to the following definitions:
Absolute leukocyte count = 2.0 x 109/l
Hemoglobin = 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/intial examinations (within 14 days prior to the start of therapy):
•MRI of the head (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); urine analysis
•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/parents/legal guardian(s) after explanation by the physician
•Negative pregnancy test in females of childbearing age
•Treatment in a study center
•Availability of the patient during the study treatment and the ability to comply with the study plan
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
None of the following conditions are permitted for a study patient:
•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 bears 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, lactation and inadequate contraception in females of childbearing age as well as inadequate contraception in males
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to investigate the efficacy of the concomitant use of nimotuzumab together with standard radiotherapy on the median progression-free survival in children and adolescents suffering from intrinsic pontine gliomas. ;Secondary Objective: Safety, quality of life and life situation ;Primary end point(s): The primary endpoint is the median progression free survival time (PFS) of the concomittant therapy of the antibody OSAG 101 and the standard local radiotherapy in newly diagnosed diffuse intrinsic pontine glomas, also named event free survival time (EFS), after the date of diagnosis.<br>A progression in the disease is defined based on RECIST criteria. <br>
- Secondary Outcome Measures
Name Time Method