NCT02197637已完成2 期
Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 16
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to determine whether oral vinorelbine is effective in the treatment of children with progressive or recurrent unresectable low grade glioma.
详细描述
The aim of this study is to determine efficacy of oral vinorelbine in children with progressive or recurrent unresectable low grade glioma, in addition to safety, pharmacokinetic, pharmacogenetic, medical costs and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TUMOR CHARACTERISTICS:
- •Histologically confirmed recurrent or progressive primary Low-Grade Glioma (LGG) defined as follow (WHO classification 2007): optic pathway glioma (OPG), pilocytic astrocytoma (PA), fibrillary or diffuse astrocytoma (DA), oligodendroglioma (OG) or oligoastrocytoma (OA)
- •Patients with OPG do not require biopsy confirmation of disease, if clinical and radiological findings as well as ophthalmological examination are unequivocal
- •Low-Grade Glioma involving the brainstem can be included in case of histological confirmation
- •Tumor has to be considered as non totally resectable
- •PATIENT CHARACTERISTICS:
- •Age 6-18 years old
- •Lansky or Karnofsky status more than 50 %
- •Measurable disease on cerebral and/or spinal MRI, with at least 1 lesion diameter superior to 1 cm
- •Patients with metastatic disease are eligible, but at least 1 lesion must be measurable as previously defined
- •Patients must have received at least 1 prior chemotherapy regimen containing carboplatin
- •Life expectancy of at least 3 months
- •Evidence of adequate organ functions, including:
- •neutrophil count (ANC) ≥ 1500/mm3 ,
- •platelet count ≥100 000/mm3 ;
- •serum creatinine < 1.5 x normal for age when the serum creatinine is ≥ 1.5 × the ULN, the glomerular filtration rate (either estimated or formal) must be > 70 mL/min/1.73m2;
- •total bilirubin< 1.5 x normal for age,
- •ASAT and ALAT < 2.5 x normal for age
- •Effective contraception for patients (male and female) with reproductive potential, and for a minimum of 3 months after the end of treatment
- •Negative pregnancy test, if applicable
- •Patients able to swallow capsules
- •Patient affiliated with a health insurance system
- •Written informed consent of patient and/or parents/guardians prior to the study participation.
- •PRIOR OR CONCURRENT THERAPY
- •Prior treatments containing vinca alkaloids like vincristine and/or vinblastine are authorized
- •Patients must have fully recovered from the toxic effects of any prior therapy before entering the study. No organ toxicity superior to grade 2 according to NCI-CTCAE v4.0
- •An interval of at least 2 months from prior radiotherapy, 6 weeks from nitrosourea chemotherapy, and 4 weeks from other chemotherapy regimen, is required
排除标准
- •Inclusion criteria failure
- •Prior treatment with intravenous or oral vinorelbine
- •Known hypersensibility to other vinca-alkaloïdes
- •Digestive pathology affecting absorption in a important way
- •Prior surgical resection of stomach or the small intestine
- •Severe hepatic failure independent from tumoral disease
- •Fructose intolerance
- •Leptomeningeal relapse without any available measurable disease on MRI (for example, leptomeningeal relapse with totally resected primary lesion)
- •Uncontrolled active infection within 2 weeks
- •Pregnancy or breast feeding woman
- •Uncontrolled intercurrent illness or active infection
- •Unsuitable for medical follow-up (geographic, social or mental reasons)
- •Patients requiring long-term oxygen therapy
- •Patients with ANC less than 1500/mm3
- •Patients vaccinated against yellow fever
研究组 & 干预措施
ORAL VINORELBINE
Experimental
Orally vinorelbine 60 mg/m2 D1, 8 and 15 Cycle of 28 days For a maximum of 12 cycles The dose of vinorelbine should be increased to 80 mg/m2 from the 2nd cycle
干预措施: ORAL VINORELBINE (Drug)
结局指标
主要结局
Progression free survival
时间窗: 9 months
no progressive disease according to RANO criteria
次要结局
- Response rate(12 months)
- Progression Free Survival PFS(36 months)
- Overall Survival OS(36 months)
- Adverse events(12 months)
- Growth Modulation Index GMI(36 months)
- Modifications of tumor aspects in diffusion and perfusion MRI(At each tumor assessment, after 3, 6, 9 and 12 cycles of treatment, at the end of study, then every 4 months during the first year post therapy, then every 6 months for 3 years, if no prior progressive disease)
- Constitutional polymorphisms of cyp3A5, ABCB1(Before the start of treatment)
- Pharmacokinetic(cycles 1 and 2, prior to the initial dose, 30 min, 1, 1.5, 2, 3, 6, 8, 10 and 26 hours post-dose)
- Medical costs(during all the study (up to 1 year))
- Health Utilities Index (HUI)(Before the treatment, then at day 1 of 1st cycle, after the 3th, 6th, 9th and the 12th cycles of study treatment, and at the end of study (up to 1 year))
研究者
研究点 (16)
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