EUCTR2008-006871-60-AT进行中（未招募）不适用
Dose-intensified Rechallenge with Temozolomide, One Week on One Week Off versus Three Weeks on One Week Off in Patients with Progressive or Recurrent Glioblastoma - DIRECTOR
niversity Hospital Heidelberg, Ruprechts-Karl-University Heidelberg0 个研究点目标入组 166 人开始时间: 2009年3月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
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
- •Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
- •Histological diagnosis of glioblastoma
- •Tissue available for the determination of MGMT gene promoter methylation in the recurrent tumor
- •Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
- •Informed consent
- •Age 18-80 years
- •Karnofsky performance score > 50%
- •Neutrophil counts > 1 500/µl
- •Platelet counts > 100 000/µl
- •Hemoglobin > 10 g/dl
- •Serum creatinin < 1.5-fold upper normal range
- •ASAT or ALAT < 3-fold upper normal range unless attributed to anticonvulsants
- •Alkaline phosphatase < 3-fold upper normal range
- •Are the trial subjects under 18? no
- •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 166
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 166
排除标准
- •Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
- •Any other prior treatment than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 as well as more than 6 cycles of adjuvant temozolomide are allowed
- •Allergy to or other intolerability of temozolomide
- •Unable to undergo MRI
- •Prior systemic or local treatment with DNA-damaging agents, tyosine kinase inhibitors or anti-angiogenic agents for any cancer
- •Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
- •HIV infection
- •Breast feeding
- •Treatment within in any other clinical trial parallel to the treatment phase of the current study
研究者
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