EUCTR2009-011252-22-DE进行中（未招募）1 期
Phase III trial of CCNU/temozolomide (TMZ) combination therapy vs. standard TMZ therapy for newly diagnosed MGMT-methylated glioblastoma patients (CeTeG)
Medical Faculty, University of Bonn0 个研究点开始时间: 2010年5月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients have to be in a cognitive state that allows them to understand the rationale and necessity of study therapy and procedures.
- •Newly diagnosed histologically proven GBM or gliosarcoma WHO Grad IV, histology confirmed by reference neuropathology (Insitute of Neuropathology, University of Bonn Medical Center, Prof. Dr. Pietsch). Histology obtained by complete resection, partial resection, open biopsy or stereotactic biopsy
- •Methylated MGMT promoter in the tumor as determined by Oncomethylome (Amsterdam) using methylation-specific PCR
- •Males or females 18-70 years of age, estimated life expectancy of at least 12 weeks
- •Karnofsky Performance Score (KPS) = 70%
- •Patient compliance and geographic proximity that allow adequate follow up
- •Male and female patients with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills, or barrier device) during and for 3 months after the trial (Pearl index <1%)
- •Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
- •Adequate organ function as described below:oAdequate bone marrow reserve:
- •white blood cell (WBC) count =3000/µl,
- •granulocyte count >1500/µl,
- •platelets =100000/µl,
- •haemoglobin = 10 g/dl
- •Adequate liver function
- •bilirubin < 1.5 times above upper limit of normal range (ULN),
- •alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) < 3 times ULN
- •Adequate renal function: creatinine < 1.5 times ULN
- •Adequate blood clotting:
- •PT and PTT within normal limits
- •Negative HIV test
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior malignancy (unless adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless the prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsquent evidence of recurrence
- •Prior chemotherapy, systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
- •prior RT to the brain
- •Concurrent administration of any other anti-tumor therapy not described in the protocol
- •Allergy or other intolerability of temozolomide or CCNU
- •Unable to undergo MRI
- •Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- •Known HIV infection, active Hepatitis B or C infection
- •Any active infection (at the discretion of the investigator)
- •Female patients that are pregnant or breastfeeding
- •Patients with reproductive potential who do not accept to use contraception during the trial and 3 months thereafter
- •Treatment in another clinical trial with therapeutic intervention or use of any other investigational agent within the 30 days before enrolment
- •Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up scheduled visits (at the discretion of investigator)
研究者
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