Know Cancer

forgot password

Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

Phase 2
20 Years
75 Years
Not Enrolling
Malignant Intracranial Tumors, Glioblastoma Multiforme, Anaplastic Astrocytomas, Anaplastic Oligodendrogliomas, Anaplastic Ependymoma

Thank you

Trial Information

Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

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 Steroids are withdrawn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.

Inclusion Criteria:

1. Hospital inpatients over the age of 20 years and under the age of 75 years, male or

2. 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.

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

5. KPS ≥ 70 for recurrent tumor

6. Life expectancy at least 3 months

7. Not pregnant or lactating.

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 liver function tests (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 <

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Jui-Chang Tsai, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University College of Medicine


Taiwan: Department of Health

Study ID:




Start Date:

Completion Date:

January 2009

Related Keywords:

  • Malignant Intracranial Tumors
  • Glioblastoma Multiforme
  • Anaplastic Astrocytomas
  • Anaplastic Oligodendrogliomas
  • Anaplastic Ependymoma
  • Photodynamic therapy
  • Malignant glioma
  • Photosan
  • Astrocytoma
  • Ependymoma
  • Glioblastoma
  • Oligodendroglioma
  • Brain Neoplasms