NCT04391062已完成2 期
A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
University Hospital, Lille2 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2021年9月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)
研究概览
简要总结
The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General status (WHO) Karnofsky Performance Status ≥60
- •Presumptive glioblastoma according to radiological criteria,
- •Surgical indication decided in Multidisciplinary consultation meeting (RCP) of neuro oncology,
- •Decision to treat the patient as part of the Clinical trial achieved in neuro-oncology RCP ("Multidisciplinary consultation meeting")
- •Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
- •Clinical neuro-oncological monitoring and long-term MRI/ TEP 11C MET scheduled at the hospital centers
- •Patient able to understand and sign voluntarily Informed consent
- •Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
- •Women of child-bearing potential should benefit of an effective contraception
- •For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
排除标准
- •Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
- •Contraindications to 5-ALA
- •Porphyria
- •Taking photosensitizer treatment
- •Severe renal or hepatic impairment
- •Bilirubin> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)> 2.5 x Maximum. rates
- •Creatinine clearance <30 mL / min;
- •Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
- •Contraindications to surgery
- •Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
- •Treatment with an experimental drug within 30 Days prior to the start of the study
- •Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
- •Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
- •Pregnant or nursing women
- •Refusal to participate or sign the consent of the study
- •Soy allergy
研究组 & 干预措施
intraoperative PDT 400J/cm²
Experimental
干预措施: Gliolan (Drug)
intraoperative PDT 400J/cm²
Experimental
干预措施: Intraoperative PDT (Device)
intraoperative PDT 600J/cm²
Experimental
干预措施: Gliolan (Drug)
intraoperative PDT 600J/cm²
Experimental
干预措施: Intraoperative PDT (Device)
intraoperative PDT 800J/cm²
Experimental
干预措施: Gliolan (Drug)
intraoperative PDT 800J/cm²
Experimental
干预措施: Intraoperative PDT (Device)
结局指标
主要结局
Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)
时间窗: 4 weeks (+/-3 days) post-PDT.
Dose level above which TDL is observed in more than 33% (i.e., d̀-\> 2 of 6) of subjects in an arm
次要结局
- Progression Free Survival (PFS)(From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months)
- Global Progression Free Survival (PFS)(From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months)
- Quality of Life Questionnaire -C30 ( QLQ-C30(Every 3 months from the signature of Consent form until relapse/death, an average 18 months)
- Overall Survival (OS)(From the Date of diagnosis of glioblastoma until the death, an average 18 months)
- Response to treatment(every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months)
- Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)(Every 3 months from the signature of Consent form until relapse/death, an average 18 months)
- Incidence of "intraoperative PDT" treatment-emergent Adverse Events(From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months)
研究者
研究点 (2)
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