NL-OMON54159招募中3 期
International cooperative Phase III trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents < 18 years. - HIT-HGG-2013
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
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 17（—）
入选标准
- •Newly diagnosed, previously untreated diffuse high grade glioma with central
- •neuropathological review including WHO grade IV/CNS WHO grade 4 and WHO grade
- •III/CNS WHO grade 3 diffuse high grade gliomas as well as diffuse high grade
- •gliomas without a distinct grade.
- •Newly diagnosed, previously untreated diffuse intrinsic pontine glioma with
- •central neuroradiological review
- •Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades
- •with central neuroradiological review
- •Patient >= 3 years and < 18 years of age at time of diagnosis
- •Written informed consent of the patient and/or the patient's parents or legal
- •guardian according to national laws
排除标准
- •Pre-treatment of diffuse WHO grade IV/CNS WHO grade 4 and WHO grade III/CNS
- •WHO grade 3 high grade gliomas, diffuse high grade gkiomas without a distinct
- •grade, diffuse intrinsic pontine glioma (as confirmed by neuroradiological
- •review), and gliomatosis cerebri (as confirmed by neuroradiological review).
- •Known hypersensitivity or contraindication to study drugs and/or dacarbazine
- •Prior chemotherapy within the last 30 days before HIT-HGG-2013 treatment or
- •radiotherapy which prevents adequate performance of radiotherapy as outlined by
- •the present protocol. This may mainly apply to patients with secondary high
- •grade glioma after previous malignant brain tumour, e.g. medulloblastoma,
- •ependymoma, craniopharyngeoma. If previous treatment does not prevent the
- •adequate performance of the outlined treatment protocol patients with secondary
- •high grade glioma will be eligible for the present trial.
- •Other (simultaneous) malignancies
- •Pregnancy and / or lactation
- •Patients who are sexually active refusing to use effective contraception (oral
- •contraception, intrauterine devices, barrier method of contraception in
- •conjunction with spermicidal jelly)
- •Current or recent (within 30 days prior to start of trial treatment) treatment
- •with another investigational drug or participation in another investigational
- •Clinical (e.g. a constitutional mismatch repair deficiency score >= 3; Wimmer
- •et al. 2014) and/or other hints (e.g. absent intratumoral immunohistochemical
- •expression of at least one of the MLH1, MSH2, MSH6, or PMS2 mismatch repair
- •proteins and/or high microsatellite instability) for an underlying biallelic
- •(constitutional) mismatch repair deficiency (bMMRD/CMMRD) or a heterozygous
- •mismatch repair deficiency (hereditary non-polyposis colon cancer
- •syndrome/HNPCC syndrome/Lynch syndrome): These patients and their relatives
- •should be offered human genetic counseling and rapid genetic diagnostics to
- •confirm or rule out these conditions. These patients might not benefit from the
- •present study treatment but maybe from other therapeutic strategies (Bouffet et
- •al. 2016). Since patients with clinically suspected neurofibromatosis type 1
- •may display similar symptoms as in CMMRD, patients with clinically suspected
- •neurofibromatosis type 1 should be also checked for CMMRD as suggested above.
- •Very poor clinical condition as defined by demand of mechanical ventilation
- •and/or demand for intravenous catecholamines and/or very severe neurological
- •damage equivalent to a coma and/or tetraplegia with complete incapability for
- •communication (deafness, blindness, mutism)
- •Known severe concomitant diseases (e.g. immune deficiency syndrome; known
- •tumour predisposition syndromes which do not affect adequate performance of the
- •trial represent no exclusion criterion a priori
- •Known HIV positivity
- •Known severe manifest hepatic disease including hepatic porphyria as well as
- •personal or family history of severe hepatic dysfunction, especially
- •drug-related
- •Known severe pancreatic disease
- •Known lethal hepatic dysfunction in a sibling during valproic acid treatment
- •Known urea cycle defect
- •Known mitochondrial diseases caused by genetic mutations within the gene
- •coding for the enzyme polymerase gamma (POLG)
- •Known severe coagulation disorders (in regards to thrombopenia see
研究者
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