EUCTR2006-001659-37-DE进行中（未招募）1 期
Phase II Study of ZK 219477 in patients with recurrent glioblastoma
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 0 人开始时间: 2006年8月25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
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
- •Patients with histologically proven glioblastoma (according to the WHO classification ; the presence of oligodendroglial elements is allowed provided these make up less than 25% of the tumor).
- •? Recurrent disease documented by MRI after failing prior therapy (usually standard RT with concomitant and maintenance temozolomide ).
- •? Patients with multifocal disease not amenable to radiotherapy are eligible, provided they have received no or no more than 1 line of prior chemotherapy.
- •? Presence of at least one bidimensionally measurable target lesion (contrast enhancing lesion) with a largest diameter of at least 2cm, based on MRI scan done within two weeks prior to registration.
- •? No prior chemotherapy for recurrent disease, or a maximum of only one prior chemotherapy regimen given as adjuvant treatment. In all cases, prior chemotherapy must be completed for at least 4 weeks (or 6 weeks if a nitrosoureas contain regimen was used) prior to registration on study.
- •? Patients who received concomitant/adjuvant temozolomide as first-line therapy are eligible.
- •? Age = 18 years.
- •? WHO Performance status 0-2.
- •? Patients must be on a stable or decreasing dose of corticosteroids for at least one week prior to inclusion/registration.
- •? No prior surgery for recurrent primary brain tumor within the last 3 months prior to registration, except if immediate (within 72 hours) post operative imaging is available documenting clearly measurable residual disease or a postoperative follow up gives evidence of a progressive and measurable target lesion, or a second measurable target lesion outside the surgical area is present.
- •? Completion of prior radiotherapy to the brain for more than 3 months prior to registration.
- •? No prior treatment with high dose radiotherapy (> 65 Gy), stereotactic radiosurgery or internal radiation therapy unless the recurrence is subsequently histologically confirmed.
- •? Patients must not be taking antiepileptic agents or be on nonenzyme inducing antiepileptic drugs (EIAED). Patients taking phenytoin, carbamazepin or phenobarbital are not eligible.
- •? For patients on EIAED, they should have been switched to non-EIAEDs with a wash-out period of at least one month.
- •? Normal hematological functions: neutrophils = 1.5 x 109 cells/l, platelets =100 x 109 cells/l
- •? Normal liver function: bilirubin < 1.5 x ULN, alkaline phosphatase and transaminases (ASATALAT) < 2.5 times the upper limit of the normal range.
- •? Serum creatinine < 1.5 x ULN.
- •? Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia.
- •Patients with stable ischemic heart disease (e.g. treated prior angina, stable under appropriate therapy) are eligible.
- •? No previous or current malignancy at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
- •? All patients (male and female) must use effective contraception methods according to CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner).
- •? Females must not be pregnant at entry or lactating.
- •? Absence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
- •There is no reason to believe that the representation of males and females would differ i
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研究者
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