NCT03897491终止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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- To determine the incidence of treatment-emergent Adverse Events (safety and tolerability) of iPDT with PD L 506 in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma.
研究概览
简要总结
The trial is an open, multicenter, explorative, pilot phase II study in a small number of patients to assess safety and efficacy of stereotactic interstitial photodynamic therapy (iPDT) with PD L 506 in newly diagnosed supratentorial IDH wild-type glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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:
- •intravaginal
- •transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation :
- •injectable
- •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.
研究组 & 干预措施
Interstitial photodynamic therapy
Experimental
20 mg 5-aminolevulinic acid per kg body weight orally four hours (range 3,5-4,5 hours) before the induction of general anaesthesia.
干预措施: 5-aminolevulinic acid (Drug)
结局指标
主要结局
To determine the incidence of treatment-emergent Adverse Events (safety and tolerability) of iPDT with PD L 506 in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma.
时间窗: 2 weeks
The incidence of treatment-emergent Adverse Events (TEAEs) of CTC grades 3, 4 and 5 within two weeks following iPDT
次要结局
- Overall survival rate at 12 months(12 months)
- Percentage of guiding catheters without kinks, cracks etc. before and after iPDT(Day 0 (Treatment day), directly before and after iPDT)
- Overall survival(From date of iPDT until the date of death from any cause, up to 66 months)
- MGMT promoter methylation status of the patient(Baseline)
- Percentage of iPDT treatments in which the laser system works properly as planned.(Day 0 (Treatment day), directly after iPDT)
- Results of investigator's assessment of patient's mental condition using Mini-mental State Examination(Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months)
- Percentage of cylindrical diffusor laser probes without kinks, cracks etc. before and after iPDT for patients treated under protocol versions prior to V7.0(Day 0 (Treatment day), directly before and after iPDT)
- Percentage of fibers/laser ports which show a maximum deviation in the output power of less than +/-10% to the pre-defined output power of 200 mW/cm diffusor length.(Day 0 (Treatment day), directly after iPDT)
- Progression-free survival rate at 12 months(12 months)
- Immune status of the patient(Baseline, 2 days, 2 weeks after iPDT and then every 3 months, up to 66 months)
- Results of investigator's assessment of patient's mental condition using National Institutes of Health Stroke Scale(Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months)
- Results of investigator's assessment of patient's condition using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Questionnaire (QLQ-C30) together with the Brain module (BN20)(Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months)
- Interstitial light transmittance and fluorescence data recorded(during iPDT treatment (up to 1 hour))
- Progression-free survival(From date of iPDT until the date of first documented progression, up to 66 months)
- Results of investigator's assessment of patient's physical condition using Karnofsky performance status scale(Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months)
- Interstitial fluorescence data recorded(during iPDT treatment (up to 1 hour))
研究者
研究点 (6)
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