ACTRN12609000978268已完成1 期
A Phase I Study to determine the Maximum Tolerated Dose (MTD) of LBH589 in Paediatric Patients With Refractory Solid Tumours Including Central Nervous System (CNS) Tumours
Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)0 个研究点目标入组 52 人开始时间: 2009年11月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 17 Years（—）
- 性别
- All
入选标准
- •* Patients must be < 18 years of age.
- •* Patient must have been histologically diagnosed with refractory solid tumours (including CNS) at time of diagnosis or relapse.
- •* Patient disease is refractory to conventional therapy or absence of conventional therapy available.
- •* Karnosfsky performance level of >=60% for patients > 10yr of age, OR Lansky performance levels >=60% for patients <=10yr of age.
- •* Life expectancy of >= 8 weeks.
- •* Fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering study.
- •* Fully recovered (ie. No evidence of graft versus host disease) from stem cell transplant (SCT).
- •* Patients with CNS tumours who are receiving dexamethasone are on a stable/decreasing dose for at least 1 week.
- •* Adequate bone marrow (BM) function tested within 1 week of registration – peripheral blood absolute neutrophil count (ANC) > 1000/ul (or 1 x 109/mL); Platelet > 100 000/ul (or 100 x 109/mL); haemoglobin > 8gm/dL (or >80 g/L).
- •* Adequate Renal function tested within 1 week of registration – age-adjusted normal serum creatinine or glomerular filtration rate (GFR) >70ml/min/1.73m2.
- •* Adequate Liver function tested within 1 week of registration – total bilirubin <=1.5 x Institutional Upper Limit of Normal (IULN) for age, serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase(ALT)) <=5 x IULN for age, and albumin >= 2g/dL (20g/L).
- •* Adequate Cardiac Function tested within 2 weeks of registration – shortening fraction of > 27% by echocardiogram OR ejection fraction of >= 50% by gated radionuclide study
- •* Adequate Pulmonary function tested within 2 weeks of registration with no evidence of dyspnoea at rest, no exercise intolerance and pulse oximetry (SaO2) >94%
- •* Adequate CNS function – seizure free for 2 months prior to study entry
- •* Adequate serum calcium, magnesium and potassium concentrations tested within 1 week of registration – all must be >= Institutional Lower Limit of Normal (ILLN) for age with or without supplementation.
- •* If female and postmenarchal, pregnancy test must be negative.
- •* If of reproductive potential have agreed to use effective contraceptive method.
- •* If female and lactating, have agreed not to breastfeed.
- •* Patient and/or their legal guardians have signed a written informed consent form
排除标准
- •* Have received myelosuppressive chemotherapy and/or biologic therapy within 3 weeks (4 weeks if prior nitrosourea).
- •* Have received local palliative radiotherapy (small port) within 2 weeks.
- •* Have received craniospinal radiotherapy within 3 months.
- •* Have received >50% radiation of the pelvis within 3 months.
- •* Have received other substantial BM radiation within 6 weeks.
- •* Have received allogeneic stem cell transplant within 6 months.
- •* Have received growth factor(s) within 1 week.
- •* Are receiving enzyme inducing anticonvulsant therapy.
- •* Are receiving medications associated with prolongation of QTc interval.
- •* Are receiving hydrochlorothiazide while on study.
- •* Are receiving Metronidazole and/or Disulfiram
- •* Have uncontrolled Sepsis.
- •* Have previously received LBH589.
- •* Have symptoms of congestive heart failure, uncontrolled cardiac rhythm disturbance, or a QTc >= 450msec.
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