Primary objective:

• Primary objective is to evaluate the efficacy of photodynamic therapy in the treatment of malignant intracranial tumors

Secondary objective:

• Secondary objective is to evaluate the safety of photodynamic therapy in the treatment of malignant intracranial tumors

Condition	Intervention	Phase
Malignant Intracranial Tumors Glioblastoma Multiforme Anaplastic Astrocytomas Anaplastic Oligodendrogliomas Anaplastic Ependymoma	Procedure: Photosan (Device), LumaCare™ Lamp Model LC-122M (Device)	Phase II

Further study details as provided by National Taiwan University Hospital:

Primary Outcomes: 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.
Expected Total Enrollment:  5

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 Steroids are withdrawn 2-3 days prior to sensitization.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.

Ages Eligible for Study:  20 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Hospital inpatients over the age of 20 years and under the age of 75 years, male or female.
2. Patients who are diagnosed as primary or recurrent malignant intracranial tumors (Grade III or Grade IV gliomas defined by the WHO classification), including anaplastic astrocytomas, anaplastic oligodendrogliomas, anaplastic ependymal tumors or glioblastoma multiforme.
3. Suitable for gross total resection on the basis of imaging studies from doctor’s point of view
4. Karnofsky Performance Scale (KPS) ≥ 60 for newly diagnosed tumor (see appendix)
5. KPS ≥ 70 for recurrent tumor (see appendix)
6. At least 3 months Life expectancy
7. Not Pregnancy or lactation.
8. Patients willing to participate in the trial and sign written informed consent

Exclusion Criteria:

1. Subject is known, suspected or has history of intolerance or allergy to porphyrin.
2. Renal dysfunction (serum creatinine > 1.5 mg/dL)
3. PT/PTT greater than 1.5 times upper limit of normal (ULN)
4. Bilirubin and LFTs greater than 2 times ULN
5. Alkaline phosphatase greater than 3 times ULN
6. γ-GT greater than 3 times ULN
7. Severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV).
8. Febrile illness and total leukocyte count < 3,000/µL and/or platelet count < 80,000/µL.
9. 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.
10. Organ transplant.
11. 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.
12. Significant alcohol, drug or medication abuse as judged by the investigator.
13. History of treatment with any investigational drug within four weeks before the start of study.
14. Tumors located within the cerebellum or brainstem

Please refer to this study by ClinicalTrials.gov identifier  NCT00243490

Jui-Chang Tsai, M.D. Ph.D.      886-2-23123456  Ext. 5422    jctsai@ha.mc.ntu.edu.tw

Taiwan
      National Taiwan University Hospital, Taipei,  Taiwan

Study chairs or principal investigators

Jui-Chang Tsai, M.D. Ph.D.,  Principal Investigator,  National Taiwan University College of Medicine   

Study ID Numbers:  33MD01
Last Updated:  December 8, 2005
Record first received:  October 20, 2005
ClinicalTrials.gov Identifier:  NCT00243490
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10