Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The addition of photodynamic therapy to standard brain tumor treatments will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant intracranial tumors.
研究概览
简要总结
Primary Objective:
- The primary objective is to evaluate the efficacy of photodynamic therapy in the treatment of malignant intracranial tumors.
Secondary Objective:
- The secondary objective is to evaluate the safety of photodynamic therapy in the treatment of malignant intracranial tumors.
详细描述
After passing Photosan® allergic test, the patients will be injected intravenously with Photosan® (2mg/kg) during 15~30 minutes, 48 hours prior to a standard craniotomy. Precautions are taken not to expose the patient in the operating room to direct room or operating light and to shield the skin of the flap during operation. Steroids are withdrawn 2-3 days prior to sensitization. After maximal resection, the surface of the tumor bed will be calculated and the generated cavity kept with a balloon containing intralipid (0.1%) or saline and/or artificial spinal fluid in it. A fiber with a spherical diffuser will be centered in the cavity and the surface irradiated with red (625~635nm) Halogen light. The dose of light irradiation depends on individual condition of the patient, usually with an energy density of 100 J/cm2 at a power density of 500 mW/cm2 to 600 mW/cm2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital inpatients over the age of 20 years and under the age of 75 years, male or female.
- •Patients who are diagnosed as primary or recurrent malignant intracranial tumors (Grade III or Grade IV gliomas defined by the World Health Organization [WHO] classification), including anaplastic astrocytomas, anaplastic oligodendrogliomas, anaplastic ependymal tumors or glioblastoma multiforme.
- •Suitable for gross total resection on the basis of imaging studies from doctor's point of view
- •Karnofsky Performance Scale (KPS) ≥ 60 for newly diagnosed tumor
- •KPS ≥ 70 for recurrent tumor
- •Life expectancy at least 3 months
- •Not pregnant or lactating.
- •Patients willing to participate in the trial and sign written informed consent
排除标准
- •Subject is known, suspected or has history of intolerance or allergy to porphyrin.
- •Renal dysfunction (serum creatinine > 1.5 mg/dL)
- •PT/PTT greater than 1.5 times upper limit of normal (ULN)
- •Bilirubin and liver function tests (LFTs) greater than 2 times ULN
- •Alkaline phosphatase greater than 3 times ULN
- •γ-GT greater than 3 times ULN
- •Severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV).
- •Febrile illness and total leukocyte count < 3,000/µL and/or platelet count < 80,000/µL.
- •Implantable electronic medical device such as a pacemaker, life-sustaining electronic medical device such as an artificial heart-lung machine, contact type electronic medical device such as an electrocardiograph, others such as an artificial middle ear, artificial inner ear, metal artificial cardiac valve and gold haemostatic clip.
- •Organ transplant.
- •History or evidence of severe illness or any other condition which would make the patient, in the opinion of the investigator unsuitable for the study.
- •Significant alcohol, drug or medication abuse as judged by the investigator.
- •History of treatment with any investigational drug within four weeks before the start of study.
- •Tumors located within the cerebellum or brainstem
结局指标
主要结局
The addition of photodynamic therapy to standard brain tumor treatments will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant intracranial tumors.
次要结局
未报告次要终点