EUCTR2014-001929-32-NL进行中（未招募）1 期
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication - BIOMEDE
Gustave Roussy0 个研究点目标入组 315 人开始时间: 2017年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 315
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
- •*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.
- •*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 (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
- •*Life expectancy > 12 weeks after the start of study treatment
- •*Karnofsky performance status scale or Lansky Play Scale > 50%.
- •*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
- •*Serum creatinine < 1,5 X ULN for age. If serum creatinine > 1,5 ULN,
- •creatinine clearance must be > 70 ml/min/1,73 m² (EDTA radioisotope
- •GFR or 24 hours urines collection)
- •*Normal coagulation tests within the local reference ranges
- •*No current organ toxicity > grade 2 according to the NCI-CTCAE version
- •4.0 especially cardiovascular, pulmonary or renal disease (, including but
- •not limited to: congenital long QT syndrome, nephrotic syndrome,
- •glomerulopathy, uncontrolled high blood pressure despite adequate
- •treatment, interstitial lung disease, pulmonary arterial hypertension).
- •*Effective and appropriate contraception for patients (male and female)
- •of reproductive potential during their entire participation in the study
- •and during 6 months after the end of treatment
- •*Negative pregnancy test evaluated in the last week in sexually active
- •females of reproductive potential
- •*Written informed consent given by the patient / legal representative
- •for treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 315
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*Spontaneous massive intratumour bleeding. Patients with postoperative bleeding will be allowed to enter the study provided the hemmorhage is controled. 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 neoplasm
- •*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 (evaluated by IHC)
研究者
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