Newly diagnosed pontine glioma
Conditions
Interventions
Product Name: Theraloc
Product Code: OSAG 101
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Nimotuzumab
Current Sponsor code: TheraCIM-HR3
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Oncoscience AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. A progression in the disease is defined based on RECIST criteria. | — |
Countries
Germany, Italy
Outcome results
None listed