EUCTR2004-005247-10-IT进行中（未招募）不适用
PHASE I STUDIES OF TARCEVATM (ERLOTINIB HYDROCHLORIDE, OSI-774) AS SINGLE AGENT IN CHILDREN WITH REFRACTORY AND RELAPSED MALIGNANT BRAIN TUMORS AND IN COMBINATION WITH IRRADIATION IN NEWLY DIAGNOSED MALIGNANT BRAIN STEM GLIOMA - Tarceva in pediatric brain tumors
FONDAZIONE SENDO0 个研究点目标入组 48 人开始时间: 2008年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •Written informed consent of patient or parent/guardian. Patients in group 1 must have histologically or cytologically confirmed malignant brain tumor. Disease must be considered refractory to first line or relapsing after conventional therapy or for which no effective conventional treatment exists. Patients in group 2 must have newly diagnosed, histologically proven malignant brain stem glioma, except pilocytic astrocytomas. Age: 1 to ≤ 21 years of age at study entry Life expectancy: at least 8 weeks No concomitant anti-cancer or investigational drug besides irradiation for group 2. ECOG Performance status <1 or Lansky-Play Scale > 70% and including children with motor paresis due to disease. Hematopoietic function: Absolute neutrophil count > 1.5 x 109/l Platelets > 100 x 109/l Hemoglobin > 8 g/dl Hepatic function: AST/ALT < 2.5 x ULN Bilirubin <1.5 ULN Renal function: Creatinine < 1.5 x ULN for age (1-15 years old: < 65 mmol/l; 15-21 years old: < 110 mmol/l); If serum creatinine is > 1.5 ULN of age, then creatinine clearance (or radioisotope GFR) must be > 70 ml/min/1.73 m2 No other serious concomitant illness No organ toxicity > grade 2 NCI-CTC version 3.0 alopecia and neurological symptoms due to disease Able to comply with study and follow-up procedures Patients must able to take oral medication. Children in group 2 with some difficulties in swallowing may be allowed For all females of child bearing potential a negative pregnancy test must be obtained before registration Patients with reproductive potential must use effective contraception
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Patients with spontaneous intratumoral hemorrhage will not be included in the study, in exception of small post-biopsy hemorrhage due to biopsy procedure Pregnant and breast feeding woman Uncontrolled intercurrent illness or active infection Chemotherapy within 4 weeks prior to study medication (within 6 weeks, if the regimen contained a nitrosourea) Radiation therapy within 6 weeks prior to study medication Any clinical or non-clinical evidence of pulmonary dysfunction or pre-existing lung disease; Severe cardiac pathology; history of myocardial infarction within the year prior to inclusion Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions Treatment with Coumarin (warfarin)
研究者
相似试验
进行中（未招募）
1 期
Phase I study of TARCEVA (Erlotinib Hydrochloride, OSI-774) as a single agent in children with refractory and relapsed malignant brain tumours and in combination with irradiation in newly diagnosed brain stem glioma. - Tarceva in paediatric brain tumoursRefractory and relapsed malignant brain tumours and newly diagnosed brain stem glioma.EUCTR2004-005247-10-GBThe University Hospitals of Leicester NHS Trust48
招募中
不适用
Three drug combination chemotherapy in previously untreated patients with locally advanced unresectable or metastatic Pancreatic CancerDiseases of the digestive systemKCT0000137Soon Chun Hyang University Hospital Bucheon32
进行中（未招募）
不适用
A parallel phase II study of Tarceva (Erlotinib) in patients with advanced non-small cell lung cancer (Stage IIIB/IV) non pre-treated by chemotherapy including dose escalation to toxicity in current and former smokers. - NDPatients with advanced NSCLC not previously treated with chemotherapyMedDRA version: 6.1Level: PTClassification code 10029521EUCTR2005-004782-41-ITROCHE44
Unknown
1 期
Erlotinib Alone or in Combination With Radiation Therapy in Treating Young Patients With Refractory or Relapsed Malignant Brain Tumors or Newly Diagnosed Brain Stem GliomaBrain and Central Nervous System TumorsNCT00360854Children's Cancer and Leukaemia Group48
已完成
2 期
A parallel phase II study of Tarceva®(Erlotinib) in patients with advanced non-small cell lung cancer (Stage IIIB/IV) not pre-treated by chemotherapy including dose escalation to toxicity in current and former smokers1. non-small cell lung cancersquamous cell lung malignancy10038666NL-OMON30374Hoffmann-La Roche8