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 tumours

The University Hospitals of Leicester NHS Trust0 个研究点目标入组 48 人开始时间: 2005年6月21日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•*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 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/WHO Performance status <= 2 or Lansky-Play Scale>=50% *Measurable or evaluable disease *Hematopoietic function; Hepatic function; Renal function: within ranges given in protocol. *No other serious concomitant illness *No organ toxicity >= grade 2 NCI-CTC AE v3.0, except alopecia and neurological symptoms due to disease *Must be able to take oral medication. Children in group 2 with some difficulties in swallowing may be allowed. *For females of childbearing potential a negative pregnancy test must be obtained before registration. *Patients wth 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

•* 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
•* Treatment with Coumarin (warfarin)

发起方

The University Hospitals of Leicester NHS Trust