DRKS00020543招募中2 期
Evaluation of the feasibility of PD L 506 for stereotactic interstitial photodynamic therapy (iPDT) in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma - GL 01
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Biopsy proven, newly diagnosed, supratentorial, unifocal, lobar located IDH wild-type glioblastoma according to the criteria of the 2016 WHO classification.
- •Not safely and/or not completely resectable, lobar located, unifocal, supratentorial IDH wild-type glioblastomas with a largest diameter = 40 mm (largest diameter of the contrast enhanced tumor, as defined by enhanced T1 MRI sequences) are eligible in case of corresponding tumor board re-estimations.
- •Potentially completely resectable, lobar located, unifocal, supratentorial, IDH wild-type glioblastoma with a largest diameter = 40 mm are eligible in case of both patient’s informed preference in favour of iPDT and corresponding tumor board recommendations.
- •Age 18 - 70 years
- •Karnofsky Performance status (KPS) of = 70 %
- •Minimal life expectancy of 3 months.
- •Patients eligible for radiotherapy plus concomitant and adjuvant chemotherapy with temozolomide:
- •- Adequate haematological function (Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 100 x 109/L, Haemoglobin > 10 g/dL (may be transfused to maintain or exceed this level)).
- •International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT) = 1,5 times of the upper limit of normal in the laboratory where it was measured.
- •Negative pregnancy test in fertile women
- •For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study. Such methods include:
- •- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •- progestogen-only hormonal contraception associated with inhibition of ovulation :
- •o injectable
- •o implantable
- •- intrauterine device (IUD)
- •- intrauterine hormone-releasing system (IUS)
- •- bilateral tubal occlusion
- •- vasectomised partner
- •- sexual abstinence
- •Written informed consent has been signed and dated prior to or at the beginning of Visit -1
排除标准
- •Glioblastomas involving the basal ganglia, the corpus callosum, the primary motor cortex, the ventricular system, multifocal tumors, and those involving the brain stem and/or the cerebellum.
- •Glioblastomas exceeding the 40 mm threshold in their largest diameter
- •Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- •Hypersensitivity against porphyrins
- •Known diagnosis of porphyria
- •Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 2.5 times the upper limit of normal in the laboratory where it was measured)
- •Manifest renal diseases with renal dysfunction (serum creatinine level > 1.5 times of the upper limit of normal in the laboratory where it was measured)
- •Severe, active co-morbidity:
- •Unstable angina and/or congestive heart failure within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •History of stroke, cerebral vascular accident, or transient ischemic attack within 6 months
- •Serious and inadequately controlled cardiac arrhythmia
- •Significant vascular disease (e.g. aortic aneurysm)
- •Evidence of bleeding diathesis or coagulopathy
- •Acute bacterial or fungal infections
- •Acute exacerbation of chronic obstructive pulmonary disease
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulopathy
- •Acquired immune deficiency syndrome; note, however, that HIV testing is not required for study entry.
- •Inability to undergo MRI (e.g., presence of a pacemaker)
- •Known intolerance to study medication
- •Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
- •Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.
- •Pregnancy or breastfeeding
- •In case of both complete absence of intra-operative fluorescence between any of the inserted light diffusers and absence of significant surgery-associated bleedings (i.e. light transmission is detectable between at least two of the inserted light diffusers), the tumor will be classified as ‘fluorescence-negative tumor’. iPDT will however be performed. Regarding efficacy evaluation, patients with fluorescence-negative tumors will be excluded from PP-, but included in the ITT-evaluation, and will be evaluated regarding safety.
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