Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication - BIOMEDE

Gustave Roussy0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 2 至 64（—）

入选标准

•*Diagnosis of DIPG (clinical and radiological, or histological in case the
•biopsy was performed before study entry)
•- Non-brainstem diffuse midline gliomas, H3K27M mutant (NB-DMG), will be
•eligible for the trial after biopsy or surgery. As biopsy and surgery is
•considered as standard practice for these locations, informed consent for the
•biopsy will not be necessary. Patient will sign the consent after the diagnosis
•to allow central review and biomarkers assessment thereafter.
•*DIPG or NB-DMG at diagnosis: no prior chemotherapy for the present cancer; no
•prior cerebral radiation therapy
•*NB : Metastatic disease allowed. Patient with metastatic disease are eligible
•for the study (including the randomised trial if diagnosis of DIPG/ NB-DMG
•confirmed). In this situation, radiotherapy will have to start within three
•weeks after the biopsy while targerted treatment will start at the end of the
•irradiation.
•*Age > 6 months and < 30 years. For children below the age of 3 years,
•inclusion in the study and medical decisions should be discussed with the
•coordinating investigator.
•*Eligible for a biopsy, or biopsy performed for diagnostic purpose and material
•available for the biomarker assessment
•*Eligible for cerebral radiotherapy
•*Patient covered by an health insurance if national requirement
•*Written informed consent given by patient and/or parents/legal representative
•for biomarkers assessment and registration in the study., *Eligibility criteria
•for the study (see above)
•*Confirmed histological diagnosis of diffuse intrinsic pontine glioma (grade
•II, III, IV WHO), or NB-DMG confirmed by central pathology review (including
•the assessment of the loss of H3K27me3 by immunohistochemistry or the presence
•of a mutation in the histone H3 variant genes). Patients without classical
•clinical and radiological diagnostic criteria who fulfil the histological and
•biological criteria of DIPG are eligible for the trial. Pilocytic astrocytoma
•and ganglioliomas are not eligible. Patients with a suspected DIPG but no
•histological confirmation could be randomised if and only if the radiology is
•typical of a DIPG as well as the short clinical history. This would need to be
•reviewed and agreed centrally. Confirmation of the diagnosis of non-brainstem
•diffuse midline gliomas, H3K27M mutant, by central review, is needed before the
•randomisation of cases of NB-DMG
•* PTEN-loss (evaluated by IHC). If the biomarker study is not contributive (ie
•no information is obtained) but the diagnosis of DIPG is ascertained either by
•a typical short clinical history and
•typical radiological appearance or by the histology of diffuse glioma with
•H3K27M trimethylation loss and eventually the detection of the H3K27M mutation
•by immunohistochemistry, the patient will be included in the trial and will
•receive everolimus.
•*Life expectancy > 12 weeks after the start of study treatment
•*Karnofsky performance status scale or Lansky Play Scale > 50%. The PS should
•not take the neurologic deficit per se into account. NB: Children and young
•adults with a worse performance status due to glioma-related motor paresis can
•be included.
•*Absolute neutrophil count > 1.5 x 109/l, Platelets > 100 x 109/l
•*Total bilirubin < 1,5 x ULN, AST and ALT< 2,5 x ULN
另有 1 项未显示

排除标准

•Spontaneous massive intratumour bleeding. Patients with post-operative bleeding
•will be allowed to enter the study provided the haemorrhage is controlled. Same
•rule applies for the other post-operative complications (infection, CSF
•leakage, absence of wound closure, subdural collection*).
•*Any other concomitant anti-cancer treatment not foreseen by this protocol
•*Any other cancer during the last 5 years
•*Uncontrolled intercurrent illness or active infection
•*Any other co-morbid condition that in the investigator*s opinion would impair
•study participation
•*Unable for medical follow-up (geographic, social or mental reasons)
•*Patient not fulfilling one of the previous eligibility criteria.
•*Patient previously treated with irradiation on the brainstem for another
•*Patient with congenital galactose intolerance, Lapp lactase deficiency or
•glucose-galactose malabsorption.
•*Patient not covered by a social security agreement accepted in the treating
•country if national requirement
•*Pregnant or breast feeding women
•*PTEN-positivity of the tumor cells (evaluated by IHC)

研究者

发起方

Gustave Roussy

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