Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243490
Recruitment Status : Withdrawn (The Trial could not get permit from Department of Health, Taiwan; Furthermore, no research fund could support the expensive (photosensitizer) photosan)
First Posted : October 24, 2005
Last Update Posted : January 12, 2010
Information provided by:
National Taiwan University Hospital

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 to evaluate the safety of photodynamic therapy in the treatment of malignant intracranial tumors.

Condition or disease Intervention/treatment Phase
Malignant Intracranial Tumors Glioblastoma Multiforme Anaplastic Astrocytomas Anaplastic Oligodendrogliomas Anaplastic Ependymoma Procedure: Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M Phase 2

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 Steroids are withdrawn 2-3 days prior to sensitization.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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors
Study Completion Date : January 2009

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 < 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243490

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Jui-Chang Tsai, M.D. Ph.D. National Taiwan University College of Medicine

Responsible Party: Jui-Chang Tsai, M.D. Ph.D., National Taiwan University Hospital Identifier: NCT00243490     History of Changes
Other Study ID Numbers: 33MD01
First Posted: October 24, 2005    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by National Taiwan University Hospital:
Photodynamic therapy
Malignant glioma

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases