EUCTR2011-004593-29-DE进行中（未招募）1 期
Phase II trial of metronomic treatment in children and adolescents with recurrent or progressive neuroblastoma - METRO-NB 2012
niversity of Cologne0 个研究点目标入组 18 人开始时间: 2015年10月9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
- 18
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
- •Newly diagnosed recurrent or progressive high risk neuroblastoma which progressed despite previous treatment (irrespective of the number of previous relapses/progressions).
- •Age: = 2 years and < 21 years
- •diagnosis of neuroblastoma confirmed according to INSS criteria (Brodeur 1993)
- •- histological diagnosis from tumor tissue or
- •- presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (VMA, HVA) in blood or urine
- •High risk neuroblastoma as defined by
- •- INSS stage 4 (INRG stage M) neuroblastoma, > 1 year at initial diagnosis, or
- •- MYCN amplified neuroblastoma of any stage
- •Recurrence (from CR) or progression (from PR or SD) is defined by detection of new lesions or >25% increase of pre-existing residual neuroblastoma (according to INSS criteria).
- •Presence of measurable or evaluable disease
- •Minimal interval between start of trial medication and preceding anti-cancer treatment is 4 weeks after chemotherapy, 6 weeks after radiotherapy, and 12 weeks after myeloablative therapy
- •Life expectancy > 3 months
- •Good to moderate general condition (Lansky/Karnowski performance scale = 60)
- •No serious active infection
- •Spontaneous recovering blood counts
- •Physical and psychosocial ability to comply with scheduled follow-up and with management of toxicity
- •Females of childbearing age must have a negative urine pregnancy test prior to starting the study drug
- •Written informed consent of parents or legal guardian and / or patient if applicable according to age and status of psycho-intellectual development
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Minimal residual disease status (only) without unambiguous measurable or evaluable disease
- •Patients unable to swallow trial medication
- •Any concomitant anti-cancer treatment (e.g. other cytostatic drugs, small molecules”, antibodies, radiotherapy, surgery of tumor or metastases)
- •Treatment with medication that interact with study medication (see 4.7.6.1) that cannot be discontinued at least one week prior to the start of trial medication and for the duration of the trial
- •Intake of antihypertensive drugs, e.g. calcium channel blockers
- •Established hypersensitivity to the active or one of the other constituents or metabolites of the trial medication
- •Severe medical or psychosocial conditions preventing trial participation and/or any of the following
- •oPeripheral neuropathy or constipation CTCAE grade 3 or 4
- •oCardiac arrhythmias (sinus bradycardia for age, sinus arrhythmia as 2.-3. grade AV block)
- •oPre-existing recurrent symptomatic bronchial asthma
- •oClinically manifest Diabetes mellitus (propranolol covers symptoms of hypoglycemia)
- •oConditions with low blood pressure below age-dependent normal ranges
- •oHistory of gastrointestinal ulcer or perforation
- •oKnown active HBV, HCV or HIV infection
- •Concomitant participation in other clinical trials with investigational drugs or competing interventions including competing medications
- •Pregnant women (Females of childbearing age must have a negative urine pregnancy test prior to starting the study drug)
- •Female patients who are lactating not willing to stop breast-feeding
- •Sexually active patients who are not willing to use/ not using a highly effective contraception method
研究者
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