EUCTR2021-004631-92-DE进行中（未招募）1 期
Phase I/II dose escalation trial of radiodynamic therapy (RDT) with 5-Aminolevulinic acid in patients with first recurrence of glioblastoma - ALA-RDT in GBM
Westfälische Wilhelms-Universität Münster, C/o Universitätsklinikum Münster Geschäftsbereich Recht u. Drittmittel0 个研究点目标入组 33 人开始时间: 2022年5月6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
- 入组人数
- 33
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
- •IN1: Written patient consent after comprehensive information
- •IN2: Age >/=18 years
- •IN3: Recurrence of supratentorial glioblastoma after initial resection and adjuvant therapy (e.g. radio-chemotherapy, targeted therapies, antiangiogenic therapies as determined by the tumor board) (with planned second resection cohort 0 and 1), second or third recurrences permitted
- •IN4: Clinically indicated further radiotherapy as per decision of the tumor board as part of therapy for recurrence
- •IN5: Histological verification of recurrent glioblastoma independent of methylated MGMT promotor status when alkylating chemotherapy failed at this time
- •IN6: Karnofsky Performance Score = 60
- •IN7: For female and male patients and their female partners of childbearing/reproductive potential*: Willingness to apply highly effective contraception (Pearl index <1) during the entire study (and for including a period of at least 6 months after the last application of 5-ALA).
- •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:
- •implantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomised partner
- •male patients have to use a condom until the end of relevant systemic exposure plus a further 90-day period
- •sexual abstinence
- •IN8: Pre-menopausal* female patients with childbearing potential: a negative pregnancy test must be obtained max. 72h prior to treatment start
- •IN9: 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. In the case of documented or suspected Gilbert’s disease bilirubin < 3 times ULN.
- •IN10: Adequate renal function: creatinine < 3 times above ULN; eGFR >/= 60 ml/min, Blood clotting: INR/Quick/PT and PTT within acceptable limits according to the investigator
- •* Definition: a man is considered of reproductive potential after puberty unless permanently sterile by bilateral orchidectomy.
- •A woman is considered of childbearing reproductive potential (WOCBP) or as pre-menopausal, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •EX1: Patient unable to undergo imaging by MRI, PET or contrast-enhanced CT for whatever reason (e.g. pace-maker)
- •EX2: Pregnant and breastfeeding women
- •EX3: 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)
- •EX4: Any active infection (at the discretion of the investigator)
- •EX5: Hypersensitivity against porphyrins
- •EX6: Known diagnosis of porphyria
- •EX7: Current participation in another clinical trial with therapeutic intervention or use of any other therapeutic interventional agent other than the standard therapy since diagnosis of glioblastoma
- •EX8: Known intolerance to study medication
- •EX9: Pre-treatment with other potentially phototoxic or photosensitizing substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts, products containing St. John's wort ) during the 2 weeks preceding RDT
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