Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas
About this trial
This is an interventional treatment trial for Malignant Intracranial Tumors focused on measuring Photodynamic therapy, Malignant glioma, Photosan
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- National Taiwan University Hospital