Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
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ClinicalTrials.gov Identifier: NCT00243490
Recruitment Status :
(The Trial could not get permit from Department of Health, Taiwan; Furthermore, no research fund could support the expensive (photosensitizer) photosan)
Procedure: Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M
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 Steroids are withdrawn 2-3 days prior to sensitization.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.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
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.
Keywords provided by National Taiwan University Hospital:
Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases