Status:
WITHDRAWN
Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Malignant Intracranial Tumors
Glioblastoma Multiforme
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00243490
End Date
January 1 2009
Last Update
January 12 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan