EUCTR2005-003100-11-DE进行中（未招募）不适用
Phase III Study on the effectiveness of OSAG 101 (Theraloc) in newly diagnosed intrinsic pontine gliomas of children and adolescents - N.A.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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