EUCTR2007-005537-11-DE进行中（未招募）1 期
Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia - Vorinostat in children
niversity Hospital Heidelberg0 个研究点目标入组 50 人开始时间: 2009年9月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
入选标准
- •? Children and adolescents (3-18 years) with relapsed or therapy-refractory solid tumor, lymphoma or leukemia following standard first-line or relapse protocols in pediatric oncology
- •? Diagnosis confirmed by one of the Pathological, Radiological or Study Reference
- •Centers recognized by the GPOH
- •? No other simultaneous anti-neoplastic treatment or radiation during the study and two weeks before enrolment
- •? Sufficient general condition (Lansky Score >50%)
- •? Life expectancy > 3 months
- •? Liver enzymes (ALT or AST) < 5x upper limit of normal reference value, bilirubin and creatinine < 3x upper limit of normal reference value
- •? Solid tumors: leukocytes > 2000/µl, thrombocytes > 50.000/µl and adequate bone marrow function to permit evaluations of hematopoietic toxicity
- •? No CTC grade 3 or 4 toxicity from previous treatments
- •? Normal ECG
- •? Written informed consent (must be available before enrolment in the trial)
- •? Women with childbearing potential agree to use adequate contraception or to abstain from heterosexual activity throughout the study, starting with Visit 1.
- •? Sexually active male patient agrees to use an adequate method of contraception for the duration of the study
- •?Solid tumors: measurable disease activity according to RECIST criteria
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? History of deep vein thrombosis or pulmonary embolism
- •? Pregnancy and lactation
- •? Patient with concomitant treatments and/or anti-neoplastic treatment such as chemotherapy, immune therapy, and differentiation therapy, other targeted therapy, radiation. The use of valproic acid as prior antiepileptic therapy is allowed with a 14-day washout period. Washout will be ensured by determining valproic acid plasma level before enrolment.?
- •Prior exposure to Histone Deacetylase Inhibitors
- •? Known active HBV, HCV or HIV infection
- •? Patient with concomitant treatments such as amber [Hypericum perforatum], plant extracts, vitamins, and other anti-oxidative compounds
- •? Participation in other clinical trials or observation period of competing trials, respectively
- •? Patient is unable to swallow vorinostat suspension or capsules
- •? Patient on coumarin-derivative anticoagulants
- •? Any other medication which could accentuate known dose-dependent adverse effects of the study drug, for instance bone marrow depression or QT-prolongation
研究者
相似试验
进行中（未招募）
1 期
A clinical gene therapy study with hematopoietic stem cells for the treatment of patients suffering from a malignant neoplasm of the central nervous systemGlioblastoma MultiformeEUCTR2018-001404-11-ITGENENTA SCIENCE SR21
已完成
不适用
Simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancerCervical cancerCancerISRCTN76100993Barts and The London NHS Trust (UK)44
进行中（未招募）
不适用
A prospective phase II study on dose escalation using PET based adaptive IMRT stage II-III non small lung cancerStage II-III Non small lung cancerEUCTR2011-003124-12-BECliniques Universitaires Saint Luc
已完成
不适用
A phase I, open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3326595 in subjects with solid tumors and non-Hodgkin*s lymphoma.solid tumors, non-hodgkin's lymphomasolid tumors and non-Hodgkins lymphomaNL-OMON53127GlaxoSmithKline39
进行中（未招募）
1 期
ATA-200 gene therapy trial in patients with LGMDR5limb-girdle muscular dystrophy type R5 (previously named LGMD2C)MedDRA version: 20.0Level: PTClassification code: 10028356Term: Muscular dystrophy Class: 100000004850CTIS2023-506440-16-00Atamyo Therapeutics6