EUCTR2009-013421-42-AT进行中（未招募）不适用
A phase II, randomized, open-label, multi-centre study of weekly APG101 + reirradiation versus reirradiation in the treatment of patients with first or second progression of glioblastoma - APG101 in glioblastoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 83
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
- •Signed Informed Consent
- •Male and female patients with a local recurrence / progression of glioblastoma and either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence
- •Not more than two prior therapy regimens including one or two resections, one or two chemotherapies, of which one must have been TMZ-containing and one radiotherapy for the brain tumour
- •Diagnosis of glioblastoma must be proven histologically and progress / recurrence of glioblastoma must be documented by MRI. MRI images must not be older than 2 weeks before randomisation / start of RT
- •Candidate for reirradiation with recurrent tumour visible on MRI-T1 (Gd) and with the largest diameter measuring 1 to 4 cm
- •Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy
- •At least 8 months since the end of preirradiation
- •at least 18 years old, smoking or non-smoking, of any ethnic origin
- •Karnofsky performance index (KPI) = 60%
- •Suitable veins or existing port system for intra-venous infusion
- •adequate contraception
- •Stable or decreasing treatment with steroids within 5 days before treatment start
- •Laboratory results (urine, blood count, chemistry, creatinine) without clinically significant abnormalities or
- •Neutrophile counts > 1 500/µl
- •Platelet counts > 80 000/µl
- •Haemoglobin > 10 g/dl
- •Serum creatinine < 1.5-fold upper normal range
- •Bilirubin, ASAT or ALAT < 2,5-fold upper normal range unless attributed to anticonvulsants
- •Alkaline phosphatase < 2,5-fold upper normal range
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Unable to give informed consent for this study
- •Unable to undergo MRI
- •Prior second radiotherapy of brain, prior first radiotherapy with more than 60 Gy
- •Prior treatment with bevacizumab
- •Prior treatment with iodine seeds and brachytherapy
- •Doses to organs at risk defined by Dogan et al. (2003) exceeded or reached by prior radiation therapy; e.g. cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, a/ß=2
- •Treatment within in any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion
- •Known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III – IV)
- •Positive test results for HbsAG, anti-HCV, anti-HIV-1/-2
- •Any other condition or treatment that, in the opinion of the Investigator, might interfere with the study or current drug or substance abuse
- •Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
- •Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
- •Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
- •Pregnancy or breast feeding
- •Subject is the investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- •Vulnerable patients
研究者
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APG101 in glioblastomaGlioblastoma Multiforme (first or second progression)MedDRA version: 14.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-013421-42-DEApogenix GmbH83
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